Regulatory Compliance Specialist Resume Samples

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R Tremblay

Rosalinda

Tremblay

806 West Ways

Phoenix

+1 (555) 257 9045

806 West Ways

Phoenix

Phone

p +1 (555) 257 9045

Experience Experience

Philadelphia, PA

Regulatory Compliance Specialist

Philadelphia, PA

Gerhold, Mertz and Okuneva

Philadelphia, PA

Regulatory Compliance Specialist

Review reclassification of hazmat parts from a non-regulated to regulated category, including supplier marking/labeling and packaging
Developing procedures for new and emerging regulatory products including AIFMD
Compiling data and producing reports and metrics for various compliance and committee reporting
Influence and guide manufacturing engineering on regulatory related topics and engineering changes
Liaising with other teams within SS&C, including fund accounting, operations and Investor Services to ensure seamless client coverage on a global basis
10% - Prepare group meeting minutes; High Density Filing Room (HDFR) maintenance of Quality Agreements
Manage any Market Actions/Recalls activities including coordinating with Quality Assurance to assure that all product inventories is accounted for

Los Angeles, CA

Network Provider Regulatory & Compliance Specialist

Los Angeles, CA

Auer-Renner

Los Angeles, CA

Network Provider Regulatory & Compliance Specialist

Review work performed by others and provide recommendations for improvement
Responsible to work with Network for validation on information
Provide explanations and information to others on the most complex issues
Responsible for working with multiple vendors to assure their files are submitted to UHN timely to prepare the whole file
Solve complex problems and develop innovative solutions
Perform complex conceptual analyses
Job scope includes supporting markets and managing team for Regulatory Filings

present

Philadelphia, PA

Senior Regulatory Compliance Specialist

Philadelphia, PA

Hauck Inc

present

Philadelphia, PA

Senior Regulatory Compliance Specialist

present

Assist in the performance of internal quality and regulatory compliance audits and the evaluation and monitoring of corrective actions
Provide oversight to the FAA Drug and Alcohol Testing Program as the Program Manager
Provide support on ad hoc initiatives as necessary
Participating in product development
Provide direction/guidance to Rockwell Collins Import Brokers
Management of C-TPAT program in a cross functional, matrixed environment
Develop and maintain regulatory procedures to ensure consistent, efficient, and compliant regulatory processes

Education Education

Bachelor’s Degree in Engineering

University of North Texas

Bachelor’s Degree in Engineering

Skills Skills

Strong understanding of Good Clinical Practice
Strong critical thinking skills and ability to independently resolve problems
Strong problem solving and critical thinking. Comfortable with ambiguity
Excellent communication skills (i.e. verbal, written) with high level of attention to details
Excellent organizational skills and ability to self-manage for managing numerous priorities
Strong knowledge of MS Excel
Strong initiative, and the ability to change in a fast changing environment
Ability to influence and make complicated subjects clear and presentable
Detail oriented, strong organizational skills, and results driven
Working knowledge of 21 CFR 820 -Quality System Regulation, ISO 13485, MDD 93/42/EEC and IVDMDD 98/79/EC

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Regulatory Compliance Specialist Resume Examples & Samples

Preparing and reviewing SEC Form PF, Form CPO-PQR, AIFMD, Form 13F and other regulatory reports for clients, ensuring their accuracy and as well as ensuring deadlines are met
Liaising with other teams within SS&C, including fund accounting, operations and Investor Services to ensure seamless client coverage on a global basis
Efficiently managing multiple client relationships, monitor client satisfaction, as well as ensure any client requests are managed on a timely basis
Acting in a consultative manner to clients, updating clients on new issues and industry requirements, in addition to updating clients on any changes/enhancements to existing products and new service offerings
Significant input into system development, including assisting with the firm’s implementation of its regulatory solutions offerings with clients
Developing procedures for new and emerging regulatory products including AIFMD
Resolving issues and taking on special projects and tasks as assigned
Bachelors degree in accounting, finance, or related field
2+ years experience in the finance industry
Working knowledge of financial products, especially fixed income and derivatives
Prior hedge fund experience working at an asset manager, audit firm or an administrator
Prior experience with regulatory reporting a plus
Capability to implement and improve structured processes
Strong knowledge of MS Excel
Form PF, CPO-PQR, and AIFMD experience is a plus

Regulatory Compliance Specialist Resume Examples & Samples

50% - Quality Questionnaire management; Maintain Approved Supplier lists
20% - Track audit observations and events/issues that may impact audit schedule
10% - Assist with metrics creation
10% - Maintain SAP profiles for raw material suppliers, contract test labs, and contract
Bachelor’s Degree and 1-2 years of relevant experience

Senior Regulatory Compliance Specialist Resume Examples & Samples

FAA/NAA liaison activity on various MRO regulatory matters
Assistance with the development of regulatory strategy and requirements for maintenance and repair of PurePower engine programs
Assisting in the implementation of new FAA/NAA regulatory requirements at P&W
Analyzing potential regulatory requirements, which affect P&W/UTC policies/procedures, and preparing draft PW/UTC position responses to the appropriate regulatory agencies on those requirements
Assisting, as requested, P&W efforts in response to FAA/NAA investigations and audits
Providing mentoring and guidance to P&W and UTC personnel on commercial aviation Production and MRO regulatory requirements
Provide oversight to the FAA Drug and Alcohol Testing Program as the Program Manager
Participate on the P&W GIDEP Team
Support the P&W Counterfeit Parts Program
Participate in department ACE initiatives
Provide analytical support in the collection of RCO metrics
Provide support on ad hoc initiatives as necessary
Finance

Regulatory Compliance Specialist Resume Examples & Samples

Creating, establishing and then managing in collaboration with other members of the Quality and Regulatory organization, self-inspection and supplier inspection programs for Canon BioMedical, Inc. (CBMI) and health technology partners at Canon Virginia, Inc. (CVI), Canon Information and Imaging Solutions (CIIS) and Canon USA (CUSA). This will include the generation and maintenance of site and functional based self-inspection schedules, and the required SOPs and forms required to execute the inspections
This position will be a critical resource and subject matter expert regarding the hosting and execution of inspections, whether they be self-inspections or by external stakeholders such as US FDA, ISO Registrars and Notified Bodies. These activities will include establishing a training program regarding how to participate in and support successful inspections, or inspections with positive compliance outcomes
This position will also lead the coordination and management of a post-market compliance program that will include executing on the Quality System Policy (QSP) and associated SOPs regarding customer complaint management and adverse event reporting (e.g. MDRs) to FDA and other regulators as required
Experience performing internal and supplier inspections against regulatory standards
Proficient in using Microsoft Word, Visio, Access, Excel and Lotus Notes
Strong communication and project management skills
Working knowledge of 510(k) (for both medical devices and in vitro diagnostic devices), IDE, MDD 93/42/EEC and IVDMDD 98/79/EC
Working knowledge of 21 CFR 820 -Quality System Regulation, ISO 13485, MDD 93/42/EEC and IVDMDD 98/79/EC

Global Product Regulatory Compliance Specialist Resume Examples & Samples

Audit the on-line country catalogs to ensure regulatory compliance for third party products
Conduct timely and thorough regulatory reviews to support the widest possible commercialization of third-party products. As part of the on-boarding process, the individual will review third-party product: (a) full disclosure formulae; (b) proposed claims; (c) proposed labeling; (d) proposed cautionary/warning labeling; (e) proposed on-line portal copy; (f) packaging inserts and articles; (g) componentry; (h) manufacturing records; (i) safety and efficacy substantiation; (j) post-marketing surveillance information; and (k) indications of any current or recent government action/s involving the third-party vendor and their product/s,
Interact with colleagues including representatives of Legal, Marketing, Sales, Business Intelligence, IT, Finance, Supply Chain, Category Management and QA/QC
Develop an understanding and comply with the US Foreign Corrupt Practices Act and the UK Bribery Act
Work with Trade Compliance team to ensure a smooth transition of products into company fulfillment centers
Regulatory review of Bodybuilding.com Forum content, posts and threads
Clear knowledge and understanding of domestic and international legislation and regulation affecting conventional food, dietary supplements and OTC drugs, with particular emphasis on the United States, Canada, the EU, Israel, Turkey and Russian-speaking markets
Experience dealing with government and private agencies charged with regulating nutritional products and the dietary supplement industry
Demonstrated business orientation and focus in daily work; ability to establish instant credibility and work effectively cross departmentally to provide appropriate feedback to colleagues and management
A hands-on approach that encourages change and creative problem solving
A Bachelor's Degree, preferably a BS in an applicable technical field, with excellent academic credentials
Possible legal training
Minimum 1 years’ experience in sports supplements industry ideally within a compliance/regulatory role
Strong analytical, communicative, organization and implementation skills
Experience of working within a hands on operational role is a distinct advantage

Regulatory Compliance Specialist Resume Examples & Samples

Bachelor's Degree in Life Sciences
Understanding and familiarity with SDS
DEA experience
1-2 years of experience in Regulatory Affairs/Regulatory Operations
Able to read, understand, and apply regulations to company's activities
Basic understanding of the rules governing development and approval of SDS, formulation
Familiarity with the structure of a regulatory submissions via web portal and/or dossier
Regulatory database competency
Some SDS authoring and/or WERCSmart experience
Experience in consumer products industry and DEA regulated products

Senior Regulatory Compliance Specialist Resume Examples & Samples

Audit, Compliance or legal research experience preferred
Strong customer focus; sense of urgency and flexible to changing circumstances and customer needs
Leader and Mentor
Up to 15%

Regulatory Compliance Specialist Resume Examples & Samples

Conduct chemistry composition determinations and health hazard assessments of new raw materials, manufactured intermediates and products in the corporate SDS and label authoring system
Support transportation classification, PPE, and handling assessments of products, raw materials and experimental products
Complete raw material approvals and material equivalency determinations for all new and reformulated materials and vendors, globally, to ensure compliance. Work with procurement, master data, and manufacturing planning organizations to implement recommendations
Contribute directly in system enhancement and development projects to maintain compliance with ever changing global hazard communication regulations and related regulatory requirements
Bachelor’s degree in Chemistry, Toxicology, Biochemistry, Biological Sciences, Chemical Engineering, Polymer Engineering or EHS directly related field from an accredited college or university
0-5 years of regulatory experience
Self-motivated and comfortable working in a team environment
Ability to handle multiple tasks and appropriately manage priorities
Detail oriented, strong organizational skills, and results driven

Regulatory Compliance Specialist Resume Examples & Samples

5-10 years of relevant experience mandatory
BS in Civil/Environmental Engineering, Environmental Science, or other directly relevant Engineering or Sciences discipline
Proficient in Microsoft excel, Microsoft word, and Adobe Acrobat
Knowledge of federal, state and local environmental regulations including but not limited to: air, hazardous and solid waste, water, chemical bulk storage, petroleum bulk storage, environmental assessments, RCRA, SARA, and CERCLA
Task and project management
Strong interpersonal skills and professionalism
This position does require travel. Travel amount is approximately 25%
This position does not manage others, however, managerial opportunities exist
Previous consulting experience is preferred
Knowledge of federal and New York State Regulations
Knowledge of Management Systems (14001, 50001, 18001)
Experience with Phase I ESAs
Experience with Environmental, Health and Safety Auditing
Education preferred: Masters
Registrations/Certifications preferred: BEAC, EIT, PE, ISO Lead Auditor

Regulatory Compliance Specialist Resume Examples & Samples

Assists with monitoring and review activities to detect compliance problems and with documentation. Assists in gathering information requested by regulatory agencies
Assist the Business Execution Risk Officer in the development and maintenance of the Regulatory Change Management process
Coordination of Regulatory Change Management process documentation with Businesses and Support Groups
Determine expected first and second line of defense ownership of new or changing rules and regulations through communication with subject matter experts
Database data entry from change management process forms
Maintenance of rule/regulation database inventory
Compiling data and producing reports and metrics for various compliance and committee reporting
Provide support to the Database Administration and Reporting function as needed, including technical support for end users, ongoing maintenance of database records and configuration, and production of ad hoc reporting

Network Provider Regulatory & Compliance Specialist Resume Examples & Samples

Job scope includes supporting markets and managing team for Regulatory Filings
Responsible for working with multiple business segments to assure current State requirements are captured for file production
Responsible for working with multiple vendors to assure their files are submitted to UHN timely to prepare the whole file
Responsible to assure whole files have all required fields populated and tasked with working with other segments to populate fields that could not be populated via reporting
Responsible to work with Network for validation on information
Liaison for Regulator Affairs
Responsible for managing team of Program Specialists
Undergraduate degree or equivalent relevant experience
5+ years experience in claims processing, provider data maintenance, contracting, or contract loading
Intermediate level of proficiency with all facility / ancillary contract reimbursement methodologies
Excellent communication skills required including ability to communicate effectively with various levels of leadership
Expert knowledge of capitation and network adequacy

Regulatory Compliance Specialist Resume Examples & Samples

Assist in the development and writing of the clinical trial protocol and other study specific documents including but not limited to: consent forms, case report forms, investigator’s brochure, recruitment materials, training slides, visit checklists, Standard Operating Procedures (SOPs), guidance documents, study manuals, etc
Liaise with investigators and disease groups on conducting clinical trials
Prepare and manage regulatory applications to federal and local agencies (FDA, NIH, IRB, etc.) and the related approval process
Monitor trial progress throughout its duration and advise/train research coordinators recruiting to the trial on protocol specifics
Verify that data entered on the Case Report Form is consistent with patient clinical notes and other source documentation (source data verification)
Act as a regulatory resource by maintaining regular contact with investigators and study teams during the course of studies to ensure that compliance is maintained
Responsible for coordinating study start up procedures and addressing logistical concerns brought up by pharmacy, radiology, neuro-oncology, billing compliance and other collaborating departments
Prepare reports as required regarding the status of ongoing studies and make necessary recommendations for contingency planning
Manage pharmacy documentation and arrange for ongoing stability testing of study drug with third party entities. Work with the project manager to address logistical concerns relating to the study drug
Provide cross-coverage for the neurosurgery research coordinators as needed
Assist project manager with new clinical trial submissions and regulatory management of additional trials as needed
Position may require some on-call work
Position may require some domestic travel
Other tasks, projects and duties as assigned by the project manager and Principal Investigators
Bachelor’s degree, which is required for this position
Two years of clinical research experience with oncology background preferred
Two year commitment strongly preferred for all candidates
Experience working in a healthcare setting
Experience with Power Point, Excel and other Microsoft office programs
Experience with database management
Available for some on-call work if required by clinical trials
Available for minimal domestic travel to other Partners Institutes
Careful attention to details
High degree of computer literacy
Strong critical thinking skills and ability to independently resolve problems
Working knowledge of data management software and procedures
Strong understanding of Good Clinical Practice
Ability to work independently under minimal supervision

Post-market Regulatory Compliance Specialist Resume Examples & Samples

Review and investigate customer complaints
Determine product failure root causes and evaluate risk of failures
Determine and analyze trend results to input into post market product failure data
Communicate with internal and external resources globally as necessary to obtain details related to customer complaints
Perform adverse event filings, including MDR and MDV reports
Evaluating regulatory impact of proposed changes to launched products
Excellent interpersonal and written communications skills
Ability to prioritize and complete tasks without direct supervision
Effective PC skills with proficiency in Microsoft office Suite, including Excel

Regulatory Compliance Specialist Resume Examples & Samples

Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners, advise on the submission strategy
Timely compile materials for license renewals, updates and registrations
Maintain regulatory files/database and chronologies in good order
Establish and maintain system for tracking changes in documents submitted to agencies or partner
Review labeling and labels for compliance with regulatory requirements
Review changes to existing products and SOPs to define the requirements for regulatory submissions
Responsible for timely registration of the facility (as required)
Maintain current knowledge of EPA, FDA, DOE, State/Federal and international regulation, guidance and standards applicable to company products
Actively participate in evaluation of regulatory compliance of document / product / process /test methods changes
Participate in research of regulatory issues and dissemination regulatory information to Production, QA, QC and R&D departments and senior management as required
Represent Regulatory Affairs on NPD product development project teams to ensure all regulatory requirements are met throughout the development process
Complete submissions to EPA, FDA, DOE and EU regulatory entities
Create and maintain product technical files
Review advertising and marketing material for appropriateness and compliance to regulatory requirements and laws
Supervise Regulatory Affairs consultants as required
Requires BA degree in a science or related field
At least 5 years relevant experience within the regulatory affairs discipline
Knowledge of US and international regulatory requirements
Skill in Word, Excel, Outlook and other Windows software
Engages, inspires, and motivates
Develops oneself
Capacity for learning
Creativity
Delivery of requirements per plan
Persists in the face of difficulties
Drives for results
Fact-based problem solving
Analyzes situations and problems
Electro-mechanical mindset

Regulatory Compliance Specialist Resume Examples & Samples

Assist with maintaining site regulatory documents
Support internal and external audits and client relationship management
Assist in training other departments related to new/updated procedures
Other related duties as directed by the Quality Compliance Supervisor or Manager
Ensure compliance with cGMPs and applicable Catalent SOPs throughout the facility
A Bachelor’s Degree in science or related degree is preferred
At least 4 years of pharmaceutical or controlled substance handling experience is preferred
Experience working in a pharmaceutical, analytical and packaging manufacturing facility is preferred
Pharmaceutical GMP regulatory knowledge base is preferred
Regulated industry/Quality experience is preferred
Experience with change control system improvements and implementation is preferred
Experience with facilitating, evaluating and routing change control documents including change risk assessments is preferred
At least one year of Internal/External Audit Experience under GMP regulatory requirements is preferred
Intermediate Microsoft Computer skills are required including experience with Microsoft Word, Excel, Project, and PowerPoint
Experience with TrackWise and other related software systems are preferred
Experience with 21 CFR 200 to 299, 1300 to End is preferred
Effective communication skills. Must have the ability to communicate verbally and in written form with all levels of the organization
Must possess and demonstrate motivational and leadership qualities
Must possess excellent problem solving and analytical skills
Must be well organized and detail and multi-task oriented
Must be able to interact effectively with a variety of individuals and personalities within and between departments and customers

Senior Regulatory Compliance Specialist Resume Examples & Samples

Provides oversight and strategic direction to Tesoro’s pipeline safety programs, which may include the Integrity Management Program, Operations and Maintenance Manuals, Operator Qualification Program, and Public Awareness Program
Maintains and updates pipeline safety programs to ensure continuing compliance with regulations and industry standards
Provides compliance support and technical expertise to regional pipeline operations personnel regarding pipeline safety regulations
Serves as a liaison with pipeline regulators and represents Tesoro during agency interactions and inspections
Conducts self-audits of logistics assets to ensure pipeline regulatory compliance and proper risk management methods are in place and functioning properly
Minimum seven years of experience in the pipeline, petroleum, or consulting industries focusing on the area of pipeline regulatory compliance and/or pipeline integrity management programs

Regulatory Compliance Specialist Resume Examples & Samples

1 Food Labelling
Develop and maintain accurate food labeling information for finished products compliant with FDA and USDA regulations
Assess the impact of formulation changes to determine timing of packaging transitions
Maintain SAP Recipe Development labeling reports
Review and approve packaging for regulatory compliance
Ensure that all on label claims are substantiated and that certifications and allergens are properly documented
Provide regulatory expertise including; but, not limited to food labeling
Provides regulatory guidance and addresses compliance related questions involving existing, new and reformulated products
2 Business Engagement
Actively participate in cross functional meetings that support product change/innovation (i.e. Stage Gate, Filter, etc.)
Support process improvements and label policy changes
Serve as a Subject Matter Expert on nutrition labeling to ensure regulatory and business needs are met
Detailed understanding of U.S. Labeling laws (food additives, nutrition, standards of identity)
Functional understanding and ability to navigate an international food regulation database
High proficiency in use of advanced computational software (i.e. Excel, Power point, SAP)
Strong problem solving and critical thinking. Comfortable with ambiguity
Excellent analytical and researching skills
Excellent communication skills (i.e. verbal, written) with high level of attention to details
Excellent organizational skills and ability to self-manage for managing numerous priorities
Strong initiative, and the ability to change in a fast changing environment
Ability to influence and make complicated subjects clear and presentable
Impeccable ethics and must maintain a high level of confidentiality

Regulatory Compliance Specialist Resume Examples & Samples

5 years of experience in Hazmat/Environmental regulation compliance (Hazardous Material Logistics / Waste)
Certified in Hazmat/Dangerous Goods shipping for US/Canada (Land , Sea and Air)
Knowledge of national and international large format Li-Li-ion HV battery shipping regulations, practices & procedures including critical battery packaging
Knowledge of international hazardous material
German - written and verbal
Spanish - written and verbal

International Regulatory Compliance Specialist Resume Examples & Samples

Knowledge of international regulatory requirements
Ability to read, write, and speak foreign languages preferred
Computer literacy required including Microsoft Office applications

Principle Risk & Regulatory Compliance Specialist Resume Examples & Samples

Bachelor degree; science/pharmacy/medicine/nursing or other graduate degree applicable to drug/device development or regulatory oversight preferable
5+ years’ post-graduate work experience as a Quality and/or Compliance professional in a regulated industry role within a pharmaceutical /medical device trial environment, or within a Contract Research Organization (CRO). Industry accreditation (e.g. RAPS) beneficial
Previous experience in conducting vendor audits of computer systems and/or software suppliers
Active role in the management and conduct of regulatory agency inspections
Sound working knowledge of current and evolving regulation and guidance (such as 21 CFR Part 11, ICH GCP and CDISC) relating to clinical data management systems (for example Electronic Data Capture, EDC or Clinical Data Management Systems, CDMS)
Must have experience in the development, and maintenance of quality management systems and CAPA management
Must possess proven communication skills and be able to articulate effectively the Oracle Health Sciences compliance vision to internal and external personnel
Ability to manage multiple projects/priorities
Must be methodical, well organized and detail oriented. Individual must be readily adaptable to a fast-paced, multidisciplinary team-based environment but equally capable operating with limited supervision
Practical hands on experience with the application of regs to clinical data management systems
Familiarity with evolving regulatory concerns and areas of interest e.g. eSource
Ability to interact and communicate effectively with senior management and external personnel

Clinical Research Regulatory Compliance Specialist Resume Examples & Samples

Bachelor’s degree and at least three to five years of work experience in clinical/translational research compliance and/or operations in any of the following areas: Academia, Pharmaceutical Company, Contract Research Organization (academic or private sector) or Site Management Organization (academic or private), on an equivalent combination of education and experience
Experience in the following areas preferred
Coordination of clinical research studies
Advanced knowledge of regulations governing human research, including 21 CFR Parts 11, 50, 54, 56, 312 and 812, 45 CFR 46, and ICH Good Clinical Practice guidelines

Regulatory Compliance Specialist Resume Examples & Samples

To stay abreast of industry and federal regulations as cited above, and provide guidance and expertise to the global organization in the areas of regulatory compliance and quality
Participate in the independent regulatory, audit, and quality assurance function for global organization
Assist in building the customer audit program
Field customer requests and assist in scheduling audits, while coordinating and driving customer deliveries with other Risk Management & Regulatory Management personnel
Host customer audits on-site and via web sessions. Participate in customer audits as a presenter and subject matter expert in the areas of Service Delivery, validation, and product functionality and testing
Provide responses to customer audit reports and customer questionnaires
Create and manage CAPA requests until closed
Provide feedback from the customer audit program to other areas of Risk Management & Regulatory Compliance and the business unit for further improvements

Senior Regulatory & Compliance Specialist Resume Examples & Samples

Organize and chair meetings to evaluate internal and external product problems and to determine if Field (Safety) Corrective Actions are necessary. Create Field (Safety) Corrective Actions Notification and supporting documentation
Evaluate complaints and determine if Vigilance Reporting requirements apply within regulatory timelines. Complete the applicable vigilance records and obtain manager approval of the decision. (MDR, Incident, Biologics, and Accidental Radiation Occurrence (MDR/ARO)
Create and manage the completion of Post Market Surveillance (PMS) reports as assigned. Create complaints from scientific publication review for PMS
Assist in the execution and improvement of regulatory processes, interactions with regulatory agencies, participate and support audits and inspections, other duties as assigned
Knowledge of FDA 806 & 803, MEDDEV Vigilance, QMS requirements (QSR820 and ISO 13485 / ISO 9001) and regulatory submission types (local/regional)
0-3 years practical experience
Can work in an international environment, good communication skills with internal stakeholders verbally and in writing, and has strong ability to lead cross functional meetings

International Regulatory Compliance Specialist Resume Examples & Samples

Coordinate independent testing of consumer electronics products in US and foreign countries
Act as liaison with international regulatory agencies to obtain information regarding consumer electronic product standards and regulations
Prepare and submit international product approval submission packages, application updates and renewals to regulatory agencies and third party agents
Assist in providing with necessary information, documents, samples, and/or forms in order to obtain regulatory agency approval
Conduct searches for international guidelines and standards. Update International Approval database pertaining to radio, telecommunications and product safety information. Expand knowledge through work on projects
Assist in determining quotation procedures for International Approvals
Corresponds with test lab and third party agents with respect to testing, schedule, samples, paperwork, etc
Able to project manage multiple projects between test labs, third party agents, OPM and EPM from beginning to the end of the project

Regulatory Compliance Specialist Resume Examples & Samples

Assist with change control system improvements and implementation
Facilitate, evaluate and route change control documents including change risk assessments
Support audits and client relationship management as directed
Other related duties as directed by the Regulatory Compliance Supervisor or Manager
Completion of administrative duties as indicated by position

Federal Regulatory & Compliance Specialist Leader Resume Examples & Samples

A dual major/minor combination including Computer Science or Management Information Systems and Business (i.e., Accounting, Business Administration, Economics, Finance, Management, Statistics)
Electrical or other related Engineering disciplines
Mathematics

Regulatory Compliance Specialist Resume Examples & Samples

Evaluate potential non-conforming product reports and drive organizational decision on product field actions through Health Hazard Evaluations
Evaluate complaints to determine if MDR/MDV reports are required to FDA and Competent Authorities
Review NC/CAPA records to determine Regulatory Compliance assessment
Respond to or manage response to Regulatory Requests within requested timeframes
Perform recall activities including running distribution reports, sending recall communications to the field and gathering and submitting relevant documents to FDA
Initiate Health Hazard Evaluation documents in document control system and assign to manufacturing location for substantial completion
Communicate potential actions to internal stakeholders
Receive partially completed Health Hazard Evaluation documents from manufacturing location and coordinate action decision at divisional level. Complete Health Hazard Evaluation documents. Manage approval process for rapid decision making and action
Review reports of customer complaints and assess them for MDR / MDV reportability to FDA / Competent Authorities
Ensure reports to FDA / Competent Authorities are completed within required timelines
Submit initial and follow-up reports to device related Agencies as appropriate
Interact with device related Agencies on vigilance reports and incidents
Work with Quality complaint-handling personnel
Request information from the field to ensure all pertinent information is acquired to make adequate MDR/MDV decision
Draft recall communication to field and coordinate any other communication that Marketing may want to make in conjunction with field actions
Communicate recalls to FDA within 10 days of decision. Gather, organize and submit all relevant recall documentation to FDA
Submit recall communication to FDA District office and receive approvals
Manage and oversee recall communications with FDA including any additional information FDA requests in classification letters or closure letters
Oversee reporting of recall effectively to corporate entities
Drive timely recall closure by coordinating resources and product disposition in conjunction with management
Review and analyze data for trending purposes
Work from verbal and/or written instructions
Track metrics on process timeliness and effectiveness
Participate in process improvement and automation
3+ years experience as a Regulatory or Quality professional in a regulated manufacturing environment, preferably Medical Devices. Experience in Health Hazard Evaluations, MDR/MDV reporting and product recalls
Demonstrated applied knowledge of FDA and international medical device regulations and standards (CFR, MDD, QSR, ISO 13485, CMDCAS, etc.)
Ability to interface with both technical and non-technical personnel at all organizational levels
Demonstrated problem-solving and troubleshooting skills
Demonstrated ability to exhibit a positive, energetic approach to teamwork
Proficient with Microsoft Office and ability to learn Corporate systems
Demonstrate interpersonal, written English and oral communication skills
Ability to read and interpret Engineering schematics / drawings / prints
Demonstrate organizational, problem-solving, and analytical and time management skills
Ability and versatility to manage changing priorities and workflow for multiple projects and deadlines
Knowledge of manufacturing processes and demonstrated ability to advocate product excellence and quality
Demonstrate results orientation and ability to learn quickly
Demonstrated ability to respond to the urgent needs of the team, with proven track record of meeting deadlines

Senior Healthcare Regulatory Compliance Specialist Resume Examples & Samples

Monitor regulatory guidance sources to determine and communicate impact and strategize on solutions
Identify, investigate, document, and resolve complex compliance issues from a legislative/regulatory standpoint, judiciously engaging regulatory agencies as necessary
Assist in developing business processes and procedures; developing and presenting in-depth education and training and documentation regarding new and updated regulations to account teams, internal business groups, and customers
Facilitate and monitor customer compliance audits
Consult with project teams by outlining applicable regulations and assisting with determining how systems should respond given specific scenarios
Provide support to internal associates, external customers, and regulatory agents regarding compliance matters

Regulatory Compliance Specialist Resume Examples & Samples

Minimum of 3 years previous bank compliance experience
Experience in an audit environment
Thorough understanding of federal compliance regulations for financial institutions
Must work under minimal supervision
Must successfully pass background investigation and drug screen according to company policy
Must be able to get along with co-workers and work effectively in a team environment

Field Regulatory & Compliance Specialist Resume Examples & Samples

Supports regulatory analysis, including the review, summarization and dissemination of key regulatory updates and changes
Coordinates the review and investigation of state contract requirements. This function involves interviews, document gathering, investigation summary, recommendations and follow-up. It also involves implementing a system of cataloguing, tracking and trending all investigations
Coordinates site visits by Federal and State regulators. This function involves developing work plans, collecting deliverables, reviewing and quality checking deliverables, mock interviews, and site visit facilitation
Supports the development of regulatory process flows, with eye toward documentation of departmental processes, report generation, and process improvement
Participates in regulatory/compliance-related audits, including the review of departmental documents, interview of departmental staff, summarizing results and implementing recommendations
Supports the design, development and implementation of the Regulatory database. Ensure all key departmental processes are captured in the database for tracking and trending purposes
Supports the management of the regulatory communications process. Ensure all regulatory communications/updates are received, summarized, catalogued, disseminated and acted upon
Coordinates the filing of regulatory forms, reports, etc. Assist other departments in understanding and complying with regulatory requirements. This includes researching regulations, informing departments of regulations, and assisting as needed in developing procedures to comply, as well as drafting responses to queries by regulatory agencies
Tracks all issues referred to the Regulatory Affairs Department up to and including resolution
Develops and maintain productive relationships with all levels of management as well as regulators and other relevant external parties
Provides education and training about laws and regulations that affect operations
LI-SM1
5+ Years of experience in Managed Care/Health Insurance or Masters Degree in Business, Public Health, Health Care Administration, or related field
Familiarity with Medicare and Medicaid programs preferred
Previous State or Federal managed care compliance experience a plus
Experience in effectively presenting information and responding to inquiries from employees, regulatory agencies, and others, as necessary
Experience in reading, analyzing, and interpreting State and Federal laws, rules and regulations
Intermediate or stronger skill level with Microsoft Office including Access, Excel, Outlook and Word

Senior Water Quality Regulatory Compliance Specialist Resume Examples & Samples

Preparing internal company-wide corporate compliance guidance documents and procedures related to SCE's Construction Storm Water Management Program
Reviewing and commenting on proposed Water Quality regulation, legislation and policy
Providing storm water compliance guidance to SCE’s construction projects with regard to environmental requirements/compliance risks related to water quality
Conduct training related to construction storm water management for internal and external stakeholders
Performing site or field inspections for assessing compliance with storm water regulations, plans, and standards
Develop, review, and implement construction Storm Water Pollution Prevention Plans (SWPPPs), Water Quality Management Plans (WQMPs), and post construction and stabilization plans
Lead permitting and project specific technical analysis such as RUSLE2 per the California Construction General Permit (CGP)
Review and comment on Proponent’s Environmental Assessments (PEAs), Environmental Impact Report / Environmental Impact Statement (EIR/EIS) documents
Managing contracts and purchase orders, consultant oversight, budget management, invoicing, accounting, and reporting
Preparation, review, and submittal of regulatory reporting documents (i.e. Annual Reports, AdHoc Reports, Corrective Action Plans, etc.)
Bachelor's Degree in Engineering, Environmental Science, Hydrogeology, Physical or Natural Science or a related field
Must have minimum of 5 years of experience in the field of environmental compliance performing complex analysis, consulting, and providing recommendations
Must qualify for Qualified SWPPP Developer/Qualified SWPPPP Practitioner (QSD/QSP) and capable of obtaining certification within first year of employment
Seven or more years of work experience in the Water Quality field
Valid QSD / QSP certification in good standing
Demonstrated experience working with laws and regulations related to the Federal Clean Water Act and the State of California Porter-Cologne Act and local ordinances
Demonstrated experience working with storm water permits, programs, and procedures including the statewide storm water CGP experience providing guidance on Best Management Practices (BMP), design effectiveness and implementation
Demonstrated strong oral and written communication skills, and be customer focused to provide guidance to internal clients, to respond to agency requests, and to represent the Company at public meetings with agencies
Demonstrated ability to work effectively in a team environment, under changing conditions, with occasional high-pressure situations and deadlines
Demonstrate strong planning, organizing, prioritizing, and coordination skills to ensure timely completion of projects
Demonstrated ability to integrate work across relevant areas, develop the business and services to enhance customer satisfaction and productivity, manage risks and safety appropriately, develop and execute business plans, manage information, and provide exceptional service to internal and external customers
Demonstrate effective decision making, results delivery, and the ability to stay current with relevant technology and innovation
Demonstrate strong ethics, influence and negotiation, leadership, and the ability to effectively manage stress and engage in continuous learning
Demonstrated ability to self-motivate with the ability to function effectively with minimal supervision
Demonstrated experience maintaining reference information and databases using Microsoft Word, Excel, Visio, and PowerPoint
Demonstrated ability to follow SCE safety protocols and safe work practices

Regulatory Compliance Specialist Resume Examples & Samples

CMC Documentation Management
Performs quality risk assessments, investigations
Performs/supports internal audit program
Performs documentation review and gap assessment to ensure site documentation meets corporate standards and documentation
Solid experience and understanding of health authorities’ expectations for dossier content
Strong understanding of requirements for global regulatory filings (US, EU, JP)
Strong project management/facilitator skills to oversee dossier development and review meetings and responses to health authority questions
Strong communication (written and verbal) skills
Consistently demonstrate initiative and attention to detail

Licensing & Regulatory Compliance Specialist Resume Examples & Samples

Bachelor’s Degree in Business (or related field)
Experience in regulatory or compliance role, preferably in healthcare or other regulated industry
Ability to manage and prioritize multiple tasks
Paralegal training/experience
Experience with local (e.g., state/county/municipal) business filings, including business licenses

Regulatory Compliance Specialist Resume Examples & Samples

Submit Mandatory MedWatch Reports and Periodic Adverse Drug Experience Reports to the FDA and appropriate regulatory authorities within timeframes established in Standard Operating Procedures (SOP’s) and federal regulations
Maintain complaint database to monitor trends in adverse and product quality reports over time, to determine any significant variance
Document and prepare reports related to recall activities and field alerts
Communicate effectively with customers to gather information regarding product complaints (including Prescription, OTC, medical device and animal health)
Assigning, monitoring and reviewing investigational tasks
Management and organization of a large and time sensitive work flow; including contacting consumers and healthcare professionals to obtain and document information relative to product quality complaints and adverse events. (TrackWise experience strongly preferred)
Document all activities in a manner that is detailed, accurate and easily understood
Involvement in revision and creation of internal SOPs
Ability to read and interpret associated regulations (Knowledge of the FDA Quality System and Regulations (21 CFR Part 210, 211, 314, 514, and 820)
Be able to work effectively in a team environment as well work independently
Prepare registrations for drug and medical device listings
Assist during internal and external audits, including regulatory inspections pertaining to complaints and ADEs

Field Regulatory & Compliance Specialist Resume Examples & Samples

Performs comprehensive, complex regulatory analyses, including the review, summarization and dissemination of key regulatory updates and changes
Coordinates site visits by Federal and State regulators. Develops work plans, collects deliverables, reviews and quality checks deliverables, and conducts mock interviews and site visit facilitation
Develops regulatory process flows, including the documentation of departmental processes, report generation, and process improvement
Provides project leadership for regulatory/compliance-related audits, including the review of departmental documents, interview of departmental staff, summarizing results and implementing recommendations
Supports the design, development and implementation of the Regulatory database. Ensures all key departmental processes are captured in the database for tracking and trending purposes
Coordinates the filing of regulatory forms, reports, etc. Provides guidance to other departments in understanding and complying with regulatory requirements. This includes researching regulations, informing departments of regulations, and assisting as needed in developing procedures to comply, as well as drafting responses to queries by regulatory agencies
Provides guidance, direction and mentoring to lower level staff members
SC Only: Coordinates and facilitates WellCare members’ access to SCDHHS South Carolina Department of Health and Human Services waiver programs
Participates in strategy meetings and make recommendations and provide feedback on WellCare processes relative to the state’s needs
Positively positions WellCare with constituents
Serves as an advocate for WellCare at events and activities
LI-RR1
Preferred A Master's Degree in Business, Public Health, Health Care Administration
Required 5+ years of experience in Managed Care/Health Insurance
Required Other Previous State or Federal managed care compliance experience
Required Other Experience in verbal/written communication and presentation skills sufficient to present information and respond to inquiries from employees, regulatory agencies, and others, as necessary
Required Other Experience in reading, analyzing, and interpreting State and Federal laws, rules and regulations
Intermediate Ability to work within tight timeframes and meet strict deadlines
Intermediate Ability to effectively present information and respond to questions from peers and management
Intermediate Ability to multi-task
Intermediate Other Ability to exercise good judgment under pressure
Intermediate Other Solid knowledge of Medicare and Medicaid programs
Intermediate Other High level of integrity
Required Intermediate Microsoft Access

Regulatory Compliance Specialist Resume Examples & Samples

Review reports of customer complaints and assess them for regulatory reporting
Submit initial and follow-up reports to device related agencies as appropriate
Develop statistical process controls and analyze complaint data
Work with customers and sales forces to resolve complaint issues
Prepare written customer communications by translating technical medical device complaint investigation reports into customer letters
Process Additional Information (AI) request letters from the FDA
Work and train other departments on their complaint handling responsibilities
Assist in determining when product field actions are required in accordance with procedures
Assist in completing product field action documentation
Assist in developing solutions and processes to manage complaints and to prevent further complaints
Maintain current on CHS TrackWise system and provide training as needed
Participate in all post-market surveillance activities as needed and faciliate Post Market Surveillance Meetings
May review and approve non-conformances and planned deviations
May provide backup phone support to the complaint hotline
May work with pre-market Regulatory personnel in developing post-market product requirements

Regulatory Compliance Specialist Resume Examples & Samples

Proven interest in financial markets and technologies will be considered very creditable
Proficiency in the Swedish and English language, also in formal writing
Self-motivated and results oriented with high integrity
Experience from working in cross-cultural and/or cross-department enviroment

Senior Regulatory Compliance Specialist Resume Examples & Samples

Reviewing and drafting policy forms, endorsements, policyholder notices and all related legal correspondence for adherence to state insurance laws
Coordinating and submitting insurance rate, rule, form, and other regulatory filings to state insurance departments
Monitoring all state insurance laws, regulations and bulletins and forming any needed action plans to ensure company’s legal compliance
Regulatory liaison for internal and external partners
Participating in product development
Managing market conduct exams and other audits
Collaborating with external legal counsel as needed

Regulatory Compliance Specialist Resume Examples & Samples

Read, analyze and interpret timeshare law, rules and forms
Work with various departments and contacts to compile information and documentation necessary to register timeshare projects with various state agencies (i.e., Operations for budgets, Club and ITG for system information, architects and engineers for construction information, etc.)
Draft contractual documents and public offering statements for use by the sales sites
Draft Project related documents (i.e, Declaration and miscellaneous agreements)
Maintain registration related charts and files
Complete special projects as assigned
Maintain archive of state filings and master file registration exhibits
Order Public Offering Statements for sales sites
Record legal documents
2 or more years of legal, real estate, or timeshare experience in an administrative function
Proficient typing of at least 50 WPM
Proficient with Microsoft office including Word, and Excel
Demonstrated ability to handle multiple tasks with various deadlines and constraints
Associates Degree
Previous timeshare registration experience

Regulatory Compliance Specialist Resume Examples & Samples

Follows all procedures and Company policies insuring that regulatory requirements are achieved in an ethical manner
Meets commitments on time with accuracy and attention to detail
Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents. Provide interpretive assistance to all departments regarding these documents
Supports management of external and customer audits providing technical expertise in processes and documentation
Develop and manage Quality metrics and monthly Quality Report, ensuring metrics are accurate and posted in a timely manner
Manages Internal Audit program
Bachelor's degree in engineering or related discipline is required (Microbiology is highly valued)
Minimum three years’ experience in Regulatory Affairs/compliance, in a medical device company
Good working knowledge of FDA Quality System Regulation (QSR), ISO 13485, and CMDCAS requirements
Experienced with Microsoft Office Suite (Outlook, Word, Excel, PowerPoint)
Fluency in Spanish strongly desired
Ability to generate reports using data analysis, SPC analysis/tools, etc. and effectively communicate findings/proposals to various users inside and outside the organization
Ability to effectively present information to senior managers and other employees of the organization
Ability to solve practical problems and deal with a variety of concrete variables and ability to interpret a variety of instructions furnished in written and oral form
Strong interpersonal skills to work across international organization
Establishes and cultivates communication and network of support to facilitate completion of assignments
Demonstrates critical thinking and problem solving skills
Exercises judgment in selecting innovative, practical methods to achieve problem resolution
Ability to manage multiple priorities
Team oriented, ability to work in a small team, as well as independently

Nutrition & Labeling Regulatory Compliance Specialist Resume Examples & Samples

Serve as the subject matter expert in all aspects of product labeling & compliance including, but not limited to, regulatory directives on nutrition and ingredients
Leading the review of labeling and marketing material for compliance with FDA, FTC and other Federal and State requirements
Respond to external inquiries about nutrition and ingredients related to labeling or packaging; inquiries may come from customers, vendors, governmental agencies, or other organizations
Develop, coordinate, and administer internal processes that control the labeling and packing design to ensure compliance with company policy and government regulations
Review and approve product artwork, graphics, and text to ensure compliance to regulatory requirements
Compile, validate, and maintain the company’s ingredient nutrition information database
Manage all phases of the label change process including, but not limited to, document preparation, product specifications, approval notification, record retention, and correspondence
Review company websites for compliance with FDA, FTC and other Federal and State Requirements
Liaise with internal stakeholders regarding compliance matters, including the central Nutrition & Regulatory Affairs team based in the UK, with a view to streamlining process and ensuring a “right the first time” approach to product compliance
Bachelor’s degree in Food Science, Nutrition or related field of study
Minimum 3 years of experience in regulatory and nutrition with a food manufacturer
Knowledge of and experience using FDA and USDA food regulations, specifications, and labeling databases
Experience reviewing food, dietary supplements and meal replacement product recipe/specifications for compliance with regulatory requirements
Strong problem solving, organization, and time management skills
Demonstrated ability to communicate effectively both written and verbally
Ability to handle complexity, multiple projects and work under tight timelines
Ability to work collaboratively with others to bring projects to completion
Ability to work from a desk for long periods of time to review labels & guidelines

Environmental & Regulatory Compliance Specialist Resume Examples & Samples

Track waste generation for SE Region and create corresponding spreadsheets and PowerPoint slides
Ensure all logs and records required by the program for the SE Region are complete and retained as necessary
Track training compliance for all environmental training programs for the SE Region
Assist with management and recordkeeping obligations for bills of lading and manifests for the SE Region
Coordinate universal and hazardous waste pickups for the SE Region and ensure all shipping documents are properly completed and processed
Assist with Tier II reporting for nationwide program
Assist with SPCC plan compliance and tank inspection protocols for nationwide program
Assist with maintaining SOPs for SE Region
Assist with maintaining environmental program BCP plan for the SE Region
Assist with maintaining environmental management system and team’s SharePoint site for SE Region
Prepare other spreadsheets, PowerPoints, and documents as assigned
Routine filing
Participate in continuing education to remain current on environmental compliance obligations
Other tasks as assigned

Regulatory Compliance Specialist Senior Resume Examples & Samples

Identifying organizational risks and trends; making local and Williams’s recommendations commensurate with the level of risk or applicability
Work with a professional team in a collaborative and productive manner
Build effective relationships within the Operating Areas

Clin Res Regulatory Compliance Specialist Resume Examples & Samples

Minimum level of education and experience equivalent to a Bachelor’s degree(preferably in Biomedical science, nursing or related health sciences) and three to five years work experience in compliance oversight of clinical trials (monitoring, QA or auditing), study coordinator, project management, or combination thereof in any of the following areas: Academia, Pharmaceutical Industry, Contract Research Organization (academic or private sector) or Site Management Organization (academic or private) required
Knowledge and experience in the application of Good Clinical Practice (GCP) requirements is desired (e.g., ICH, FDA, etc.). Familiarity with the essential documents related to clinical studies, medical terminology and routine medical tests and procedures. Familiarity with computerized clinical data collection systems and biomedical statistics is preferred
Ability to respect and protect highly sensitive and confidential information
The candidate must possess strong interpersonal, oral and written communication skills in order to effectively and independently conduct regulatory compliance reviews and communicate findings
Strong ability to demonstrate diplomacy and negotiation skills, as well as the ability to persuade when necessary. Able to confidently interact with all levels of management including senior management, PI’s and others
The ability to develop interdepartmental relationships and form solid collaborations
Strong sense of urgency in escalating non-compliance issues
Adept in the use of computerized databases and other applications and in performing data analyses to evaluate trends and metrics
The candidate must be able to assimilate large amounts of data efficiently, exercise sound judgment and maintain composure in order to effectively handle sensitive issues, such as instances of serious clinical noncompliance
Proven project management skills, including effective planning and organizational skills, attention to detail and excellent follow through

Quality & Regulatory Compliance Specialist Resume Examples & Samples

Provide support to the Senior Director, Quality & Regulatory Compliance in the development, enhancement, standardization, execution and implementation of processes to manage the notified body audit program. Support includes coordination of facility audit scheduling and issue resolution
Support execution of the supplier quality program, including, qualifications and/or audits, routine monitoring, assessment meetings, action requests and as necessary, issue resolution
Assist in the administration of STERIS AST quality system policies, procedures and work instructions, including on-going maintenance, periodic reviews, notifications for new/revised procedures and posting documents to a central location for access
Provide support to the Quality and Regulatory Compliance team in the investigation and resolution of global CAPAs
At the direction of the Senior Director, Quality and Regulatory Compliance, support FDA and other regulatory agency responses following receipt of formal observations
Participate in quality system audits at AST global facilities as requested
Perform data analysis/trending as requested
Support continuous improvement efforts within the facility and the organization through participating in quality and performance improvement projects as requested
Support a safe, clean and secure working environment by supporting procedures, rules and regulations
Conduct yourself in accordance with the principles of the STERIS Code of Business Conduct and comply with all Company policies
Protect company confidential information by properly storing, retrieving and disseminating such information only to those authorized
Bachelor’s Degree - Scientific, Engineering, Clinical or Regulatory fields of study
Entry level position, internship experience preferred
Self-starter that is highly organized
Strong interpersonal skills – ability to work closely with people at all levels within the STERIS organization and facilitate the implementation of corrective actions; able to work effectively and professionally with external people including Customers and government officials
Excellent PC skills, including Microsoft Office applications
Ability to balance multiple high priority responsibilities on-time and effectively

Senior Regulatory Compliance Specialist Resume Examples & Samples

Management of the Corporate Duty Preference Program to include the financial tracking and reporting of duty cost savings to senior leadership
Management of C-TPAT program in a cross functional, matrixed environment
Clearance of goods through Customs agencies in accordance with applicable regulations
Provide direction/guidance to Rockwell Collins Import Brokers
Direct interface with US and International government agency representatives
Leadership of the Import Compliance team’s Root Cause/Corrective action program
Bachelor's degree in appropriate discipline or in the absence of a degree six years of related experience; identified skills and experience
US Citizenship
Experience managing all aspects of complex/strategic projects (costs, schedule, and budget) including the delegation and oversight of tasks to other organizations
US Import/Export regulatory knowledge and experience preferred (not required)
Excellent verbal/written communication skills
Experience with MS Excel and Access a plus

Senior Regulatory Compliance Specialist Resume Examples & Samples

Minimum 3 years working in a food or manufacturing plant
Successful completion of Bachelor of Science (Food Sciences preferred)
Knowledge of Canadian and U.S. government regulations on ingredient, claims and nutritional labelling

Regulatory Compliance Specialist Resume Examples & Samples

Plant Regulatory Point Person for environmental and safety programs
Responsible for disseminating new safety and environmental regulations to plant managers and staff
Responsible for development, implementation, and continuation of a uniform safety and environmental documentation and training programs
Responsible for the development, implementation, and continuation of an industrial hygiene monitoring program and engineering controls and/or PPE selection
Maintains Plant Compliance Calendars
Provide GRMS coordination for the plant
Provide direction to insure compliance with OSHA regulations
Take or meet injured employee at the hospital when injured
Support response to OSHA complaints
Ensure overall compliance with all environmental laws, standards, and regulations, including existing and pending site permits (CAA, NPDES, Local Ordinances, etc.)
Manage compliance projects as needed
Develop all environmental reports required by permits including SARA 312, SARA 313, CAA, CWA, RCRA, and Local Ordinances
Responsible for ensuring all waste generated from the facility is packaged, handled, transported, disposed of, and tracked in a manner that meets and/or exceeds Federal, State, and Local regulations
Requires a Bachelor’s degree and a minimum of three years related experience Ability to prioritize tasks and handle multiply projects simultaneously
Provide leadership to others through example and sharing of knowledge/skill Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form

Regulatory & Compliance Specialist Resume Examples & Samples

Publishes new safety and environmental regulations to plant managers and staff
Utilize GPS processes, driving zero losses, and upholds the culture of Glanbia non-negotiables
Active participation and/or ownership of Plant Pillars
Develops, implements, and continues a uniform safety and environmental documentation and training programs
Develops, implements, and continues an industrial hygiene monitoring program and engineering controls and/or PPE selection
Maintains OSHA plant logs
Take injured employee to the hospital when injured
Conducts Root cause analysis investigations
Responsible for Tier II, Form R, and stormwater inspections/reporting
Conduct bi-annual plant safety inspections
Ensures compliance with all safety laws, standards, regulations, and policy (OSHA, Workman’s Compensation, etc.)
Prepare permit modifications as needed
Bachelor’s degree and a minimum of two years related experience
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs
Provide leadership to others through example and sharing of knowledge/skill
Ability to prioritize tasks and handle multiply projects simultaneously
Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form
Ability to deal with problems involving several concrete variables in standardized situations
Basic personal computer skills including electronic mail, word processing, spreadsheet, graphics, etc
Comply with all safety policies, practices and procedures. Report all unsafe activities to supervisor and/or Human Resources
Participate in proactive team efforts to achieve departmental and company goals

Senior Regulatory Compliance Specialist Resume Examples & Samples

Bachelor’s degree in appropriate discipline, or, in the absence of a bachelor’s degree, six years of related experience
US Export/Import regulatory knowledge and experience preferred (not required)
Knowledge of SAP is preferred but not required
The individual will possess knowledge and be able to apply and interpret federal regulations as they apply to export and/or import activities. The individual must be able to self-check work to meet company, regulatory and industry requirements and guidelines
Strong written and oral communications, collaboration and research skills
Strong organizational skills and ability handle multiple, conflicting priorities among a wide array of projects and assignments
Sound judgement, professional demeanor, good work ethic and business acumen
Experience facilitating or leading projects. Requires knowledge of information flow, value stream and process mapping, business improvement tools and techniques. Understands complex systems process analysis, design and simulation in order to drive teams to understand and define the process improvements needed

Senior Regulatory Compliance Specialist Resume Examples & Samples

Interface with regulatory authorities and notified bodies as necessary to ensure LifeCell products comply with applicable requirements
Respond to regulatory authorities, customer, and distributor requests for information
Maintain regulatory files and tracking databases to ensure prompt and accurate access to LifeCell regulatory information and to provide reports to Management concerning current, pending, and future approvals
Keep abreast of changes and proposed changes to worldwide regulatory requirements related to LifeCell products and processes. Advise Regulatory Management of changes and communicate regulatory initiatives or changes to other LifeCell staff
Track external standards applicable to LifeCell products and processes, as well as the maintenance of the corporate standards library/index and communication of proposed/implemented changes to LifeCell staff
Develop and maintain regulatory procedures to ensure consistent, efficient, and compliant regulatory processes
Assist with compliance activities related to GMP and ISO regulations, ISO quality system standards, and other applicable standards and requirements
Key member of the audit team during quality inspections by FDA, notified bodies, International Regulatory Agencies, and partners
Act as a Regulatory Compliance subject matter expert and respond to requests for information during external audits and inspections
Prepare audit responses and following up on corrective actions to ensure timely and compliant closure
Assist in the performance of internal quality and regulatory compliance audits and the evaluation and monitoring of corrective actions
Participate on product teams developing new products to define global regulatory requirements
Review product and process documentation for assigned projects to ensure compliance with change control requirements and determining whether regulatory submissions or notifications are required
Special projects, as assigned
Knowledge of Quality systems for Class II and/or Class III medical devices, and/or human tissue products
Excellent oral and written communication skills, with the ability to interface effectively and professionally at all levels. Must possess strong presentation skills
The ability to work on problems of a diverse scope where the analysis of a situation or data requires an evaluation of various factors
BA or BS Degree – in a technical discipline (sciences or engineering) or equivalent experience
5-7 years Quality or Regulatory Compliance experience in an FDA and/or ISO regulated industry with demonstrated knowledge of standards, regulations, and regulatory agency practices with practical application of traditional and creative approaches to regulatory compliance practices

Senior Field Regulatory & Compliance Specialist Resume Examples & Samples

Coordinates the review and investigation of state contract requirements. Interviews, gathers documents, creates investigation summaries, makes recommendations and performs follow-up. Implements a system of cataloguing, tracking and trending for all investigations
Supports the management of the regulatory communications process. Ensures all regulatory communications/updates are received, summarized, catalogued, disseminated and acted upon
Represents the health plan at federal, state, and local government meetings
Communicates the importance of compliance and the compliance program to health plan staff, which includes promoting (1) increased awareness of the Corporate Ethics and Compliance Program, (2) understanding of new and existing compliance issues and related policies and procedures, and (3) importance of internal compliance audits
Works with different functional areas to implement mandates, regulations, and corrective action plans
Works with governmental agencies to fully understand beneficiary programs and educates staff and members and facilitate connecting members to resources
Maintains project plans for control of issue resolution
Identifies and coordinates with safety net providers to facilitate member referrals, especially for non-core benefits
Required A Bachelor's Degree in
Required previous State or Federal managed care compliance experience
Required experience in verbal/written communication and presentation skills sufficient to present information and respond to inquiries from employees, regulatory agencies, and others, as necessary
Required experience in reading, analyzing, and interpreting State and Federal laws, rules and regulations
Intermediate ability to work within tight timeframes and meet strict deadlines
Intermediate demonstrated interpersonal/verbal communication skills
Intermediate demonstrated written communication skills
Intermediate ability to effectively present information and respond to questions from peers and management
Intermediate ability to multi-task
Intermediate demonstrated organizational skills
Intermediate ability to exercise good judgment under pressure
Intermediate solid knowledge of Medicare and Medicaid programs
Intermediate high level of integrity
Required Intermediate Microsoft Excel
Required Intermediate Microsoft Outlook

Regulatory Compliance Specialist Resume Examples & Samples

7 years experience with hazardous liquid pipeline systems and PHMSA/DOT requirements. Experience with CO2 systems preferred
In depth knowledge of industry pipeline procedures primarily for transmission systems governed by PHMSA/DOT Part 195 regulations as well as relevant state rules affecting operations
Computer skills a must with proficiency in Microsoft Office, ISNetworld, WinDOT, Celeritas, Paradigm, and Adobe Professional. Strong database skills a plus
Working knowledge of hazardous liquid pipeline safety regulations found in 49 CFR 195
Ability to manage multiple activities and resources, expedite critical issues and meet time constraints / deadlines
Communications skills to influence others to meet compliance and regulatory requirements
Good blend of functional expertise and interpersonal skills
Knowledge of forms and procedures used to demonstrate pipeline safety compliance
Ability to prepare for and conduct a PHMSA or State audit with successful results
High School or equivalent . College classes or college degree a plus. Technical background preferred

Regulatory Compliance Specialist Resume Examples & Samples

Enter/maintain all ingredients, plant and product information in Product Vision and generate nutrition and ingredient labels for new and existing finished products
Ensure nutrition and ingredient labels are electronically available to sales, key account managers, marketing, R&D and customers
Manage supplier and raw material documentation and procedures. This includes liaising with suppliers directly, communicating with plant contacts, and connecting with cross-functional teams
Remain abreast of current and upcoming regulatory changes within Health Canada, Canadian Food Inspection Agency, U.S. Food and Drug Administration, USDA, other regulatory agencies as required
Ensure all product labels (ingredient declaration, nutrition panel, allergen statement) meets government standards and is representative of all associated manufacturing plants
Provide guidance and support to the marketing, R&D, sales, food service or other internal teams on risks associated with labelling such as wording of romance copy, developing appropriate claims and product names
Liaise with CFIA/FDA inspectors to identify discrepancies between product formulations and labelling infractions, outlining action plans to correct non-compliant issue and follow up with regulatory officials with corporate correspondence
Maintain updated spreadsheets of packaging artwork files, finished product list, raw materials and suppliers
Respond to customer inquiries, complete customer documents/forms, and upload information to customer-owned databases
Provide assistance to manufacturing plants to ensure requirements for 3rd party and/or customer audits are met

Regulatory Compliance Specialist Resume Examples & Samples

Preparing SEC Form PF, Form CPO-PQR, AIFMD, Form 13F and other regulatory reports for clients
Managing client relationships
Significant systems development responsibilities
Coordinating New York operations with offices worldwide for seamless client coverage
Developing new regulatory products including AIFMD
Preparing OPERA standard due diligence report for clients
Developing solutions to analytical problems independently
Bachelors degree in accounting or related field
1+ years experience in the finance industry
Prior hedge fund accounting experience
Prior experience with regulatory reporting
Form PF, PQR, and AIFMD experience is a plus
CPA a plus

Regulatory Compliance Specialist Resume Examples & Samples

High school degree or GED required. A Bachelor's degree is preferred
Working knowledge of federal government or regulatory compliance
Superior organizational skills and attention to detail with ability to prioritize,multi-task and meet deadlines
Ability to function as both a strong team player and as an independent consultant, as necessary
Above average proficiency in Microsoft Suite office programs
Familiarity with industrial gas and hardgoods business a plus

Regulatory Compliance Specialist Resume Examples & Samples

Work with training developers on computer based training for annual population density survey
Prepare and conduct site specific training for targeted field locations, on annual population density survey. ArcGIS, Word & PowerPoint
Perform structure editing based on population density survey from operations via ArcGIS versioning tools
Prepare annual study to determine locations where rich gas may impact HCAs on laterals or mainlines
Perform analysis and manage results on HCAs and Class Location, utilizing third party software
Prepare and file Management of Change documents. Word, Excel, Bluebeam or Adobe Acrobat, SharePoint
Determine new pipeline replacement and hydrostatic projects, based on changes to Class Location
Accompany project management on scoping trips for pipe replacement projects
Provides coordination and support during PHMSA integrated inspections and Integrity Management Plan (Subpart O) audits
Reviews and approves written plans for strength tests/pipeline uprates, and determines and documents MOPs/MAOPs
Assists the Pipeline Safety Engineers in responding to facility/pipeline incidents and coordinates communication and reporting with PHMSA and applicable state agencies
Participates in industry groups to represent Williams, as necessary
An Associate’s degree or equivalent experience required
At least 6 years of technical experience in the natural gas or petrochemical industry
Ability to work independently under minimum supervision
Perform varied tasks and projects of moderate complexity requiring the application of standard techniques, procedures, and criteria
Complete routine technical assignments completed independently
Ability to perform some technical evaluation and fundamental engineering judgment is required
Possess a developed understanding of industry and operating requirements
Must possess the ability to understand new technologies and work closely with personnel across OAs/FAs
Ability to apply economic evaluations and present recommendations
Knowledge of pipeline operations and pipeline safety regulations (Part 192 & 195), and GIS tools/PODS database preferred
Excellent oral and written skills, the ability to organize, coordinate and negotiate solutions as well as skills in computer applications
Must be detailed oriented and able to instruct, analyze, evaluate, and provide technical interpretations while at the same time deal with ambiguity and maintain integrity and trust with internal and external customers
Experience with the following tools is needed: ArcGIS v10.3, PipelineOffice Gas HCA, Gas HCA Analyst, and Intrepid

Regulatory Compliance Specialist Resume Examples & Samples

O Providing services needed for medical device complaint and failure issues, including, but not limited to, intake, assessment, follow-up actions, tracking, record retention and reporting for the U.S. and Canada,
Demonstrate a detail-oriented nature with the ability to track, organize and prioritize multiple simultaneous tasks
Strong computer skills in Microsoft Office including Microsoft Excel, Microsoft Word, Power Point and Visio
Establish trust and credibility at all levels of the organization
Manage change effectively
Excellent written, verbal and interpersonal communication skills, comfortable with remote site communication
Highly motivated and self-driven with the ability to work efficiently with limited supervision
Sound problem resolution, judgment, negotiating and decision making skills

Regulatory Compliance Specialist Resume Examples & Samples

Perform surveillance rounds on inpatient, residential and partial/iop programs ensuring continuous regulatory compliance
Create and maintain (update as needed) a surveillance document with regulations and standards from Federal, State and the Joint Commission agencies
Schedule time in programs to conduct surveillance activities
Interview staff on programs, and discuss regulations, standards and Rogers policies. Provide education to staff as needed
Take immediate action on any item found to be a safety risk while conducting surveillance rounds
Prepare a findings report and send to responsible VP, Director, and Clinical Service Manager
Track action items for follow up and revisit on follow up surveillance rounds to ensure resolution
Work with program to create an action plan to mitigate future survey non-compliance
Assist during Federal, State and Joint Commission surveys as needed, conducting tours and providing necessary documents as appropriate. Assist with preparing action plans and follow up projects to address any deficiencies identified in external agency surveys
Create/revise department newsletter and post on intranet, as needed

Regulatory / Compliance Specialist, Senior Resume Examples & Samples

Drives policy and procedure process, including the design, review, cataloging, dissemination and annual updating of corporate policies and procedures
Coordinates review and investigation of Trust Program reports
Coordinates site visits by Federal and State regulators
Provides project leadership for compliance-related audits, including the review of departmental documents, interview of departmental staff, summarizing results and implementing recommendations
Supports the design, development and implementation of the Regulatory database ensuring all key departmental processes are captured in the database for tracking and trending purposes
Supports management of the regulatory communications process ensuring all regulatory communications/updates are received, summarized, catalogued, disseminated and acted upon
Coordinates filing of regulatory forms, reports, etc. and provides guidance to other departments in understanding and complying with regulatory requirements
BA/BS Degree
7+ years experience in Managed Care/Health Insurance or a Master's Degree in Business, Public Health, Health Care Administration, or related field
State or Federal Managed Care Compliance experience
Solid knowledge of Microsoft Outlook, Excel, Word, and Access

Licensing & Regulatory Compliance Specialist Resume Examples & Samples

Bachelor’s Degree in Business or Healthcare Management or the equivalent
Minimum of 1 year experience in a healthcare and/or legal environment
Paralegal training/experience preferred

Regulatory Compliance Specialist Resume Examples & Samples

Coach others in the appropriate application of regulations and standards
Manage CAPA system, participates in CAPA Review Board
Supports CAPA activity through phase ownership and/or guiding others through timely phase completions and providing constructive feedback
Prepares monthly compliance metrics related to CAPA for Management Review and Plant Review
Manages metrics collection presentations and requests
Conducts product distribution release activitites
Participates in audits by Corporate and outside regulatory agencies
Reviews changes to Corporate procedures and assesses the impact on local site procedures
Participates in Product Inquiry Reports (PIRs) as needed
Helps with coordinating Field Actions, as needed
Represents Quality Compliance in project team meetings
Minimum of 2 years medical device experience, preferably in quality systems support
Experience with Boston Scientific's Quality System
Problem solving and analytical thinker
Work independently

Regulatory Compliance Specialist Resume Examples & Samples

Ensure that all aspects of the Product Regulatory Standards, including product safety, laser safety, EMI/EMC, CSA Safety Marking, CE Marking, FCC Marking and their application to SCIEX products are determined and communicated to development engineering functions for their implementation into the design of the product, and a comprehensive test plan is developed to verify the requirements for the end product compliance
Prepares, determines and negotiates HQA Test Plans and Test Procedures for new instruments as agreed to with the Project Manager, starting with Concept Phase and updating/adapting in all subsequent phases until testing completed
Direct and/or Conduct the product regulatory tests, either in-house or at an outside test agency, generate test procedures and test reports, and maintain appropriate technical files in providing objective evidence of our compliance
Conduct all interactions with regulatory agencies to achieve and maintain compliance and obtain certifications specified for the product, including but not limited to CSA, UL, FCC, and FDA CDRH (for laser safety)
Work with project teams for the purpose of maintaining product regulatory compliance throughout the product life cycle, including approval of engineering changes for the project. Primary responsibility in R&D function is to create test plan in early lifecycle phases, keep up with design iterations, and guide teams to keep designs in regulatory/safety compliance
Conduct product safety related investigations on field reported problems or incidents
Maintain close contact with regulatory agencies globally and remain up to date with the latest standards and changes to these standards, in order to ensure continuous product compliance. These activities will include, but are not limited to, RoHS and WEEE Directives compliance
Evaluate or direct evaluation of OEM products and test procedures/facilities/reports for regulatory compliance, and provide approval for their use in our products
Maintain a small test lab for conducting preliminary product regulatory tests in-house
Influence and guide manufacturing engineering on regulatory related topics and engineering changes
Post secondary education in Electrical or Mechanical Engineering or equivalent education and experience
10+ years of product safety and EMI/EMC test experience in a similar corporate environment to SCIEX with R&D, engineering and manufacturing operations
Knowledge of product Regulatory Standards (i.e. CSA, UL, IEC, etc.) and their application to SCIEX products, including EMI/EMC and safety requirements and tests
Knowledge of global product regulatory and safety requirements, including European, North American, Chinese, Korean, Australian, and other countries (i.e. CSA mark, CE mark, FCC, FDA CDRH, RoHS, WEEE, etc.)
Ability to communicate with regulatory agencies in identifying the need for design changes and regulatory testing for the purpose of obtaining/maintaining certification for new and existing products
Knowledge on FMEA and/or Accelerated Life Testing a big plus
Knowledge of test equipment selection, functionality, operation, and calibration requirements
Familiarity with analytical instruments such as mass spectrometers, cell based analyzers, and other drug discovery and research screening instruments is an asset
Familiarity with application of statistical techniques and/or Six Sigma DMAIC and/or DFSS
Familiarity with ISO 9001 based quality management system
Excellent, clear and concise communications skills
Ability to effectively communicate, influence and teach R&D and Manufacturing teams on regulatory requirements

Regulatory Compliance Specialist Emergency Medical Service Orlando Resume Examples & Samples

Discretion when discussing personnel/patient related issues that are confidential in nature
Basic computer skills using MS Office Suites (Word, Excel, Power Point, Outlook) and Right CAD system
Creativity, initiative, and self-direction
Ability to apply and communicate regulatory requirements
Proficiency in performance of basic math functions, communicating professionally and effectively in English, both verbally and in writing
Two years of applicable clinical or didactic experience
Knowledge of core measures, public reporting, and process improvement (Preferred)
Bachelor of Science degree in Nursing OR Bachelor’s degree in a health-related field (Preferred)
Five years equivalent clinical or didactic experience (Preferred)
Current, valid State of Florida license as a registered professional nurse. (Preferred)

Regulatory Compliance Specialist Resume Examples & Samples

Support Company Initiatives, especially the Company’s 123SQP plan
Working with all regulatory agencies
Supports and advises internal and external customers and technical staff on regulatory related questions on new or existing products
Maintain electronic regulatory files in company’s controlled document management system
Attend seminars, conferences and workshops to track new trends in regulatory activities and interact with trade associations and other regulatory professionals
Responsible for regulatory initiatives and trainings
Obtains required approvals for new products including preparation of notifications or registrations with regulatory authorities such as FDA, EPA, AQMD or Kosher
Responsible for 100% on time compliance with all regulatory requirements. The regulatory agencies that we deal with are; FDA, EPA, Fire Department, LACSD, DOT, DOJ, DHS & AQMD
Act as the main liaison with Regulatory agencies
Responsible for monthly, quarterly and annual regulatory reporting and/or fees
Prepare annual regulatory affairs budget
Create and maintain regulatory standard operating procedures
Perform regulatory research and regulatory intelligence as needed and update the organization accordingly

Offshore Regulatory Compliance Specialist Resume Examples & Samples

Manages relationship between Williams, the Department of the Interior Bureau of Ocean Energy Management (BOEM), Bureau of Safety and Environmental Enforcement (BSEE), the United States Coast Guard (USCG) and the United States Army Corps of Engineers (USACE). Has oversight of BSEE, BOEM, USACE and USCG regulatory permitting and compliance issues for Williams Offshore Assets located in Federal Waters. This includes the oversight of Capital and Expense Projects as well as preventative and corrective maintenance actions
Acquires, organizes, interprets and disseminates highly technical and specialized regulatory information related to fixed and floating production systems, fixed and floating off-shore installation operations, and off-shore pipeline installation
Provides Subject Matter Expert (SME) for regulatory and compliance issues for shallow water and deepwater areas. Interpretation of regulations as they relate to new construction, modifications and day-to-day operations and maintenance activities
Provides required input for the Management of Change (MOC) process regarding impact from BSEE, BOEM, USACE and USCG regulations
Reviews and disseminates information from BSEE and BOEM Notice to Lessees (NTLs), bulletins and Notices of Proposed Rule Making from the Federal Register, and changes to the portion of the Combined Federal Regulations of the BSEE, BOEM, USACE and USCG applicable to Williams’ offshore operations
Coordinates actions required by BSEE, BOEM, USACE and USCG regulations with those required by the Williams Integrated Management System (WIMS) and provide input, feedback and necessary changes in a timely fashion when updates are required
Identifies, tracks, evaluates and develops Williams’ comments or positions, as appropriate, to key BSEE, BOEM, USACE and USCG proposed rulemakings or regulation changes
Participates with applicable industry groups to identify, track, evaluate and develop Williams’ comments or positions, as appropriate, to key BSEE, BOEM, USACE and USCG proposed rulemakings or regulation changes that affect Williams' operations on the Outer Continental Shelf
Acquires coastal permits and authorizations with required state agencies
Negotiates and executes 3rd Party Anchor Encroachments and Pipeline Crossings agreements
Coordinates with internal stakeholders to complete and submit routine compliance reports such as Marine Trash and Debris (MTAD), and Office of Structural and Technical Support (OSTS) Platforms Inspections
Coordinates with Legal and Risk Management Departments to complete Oil Spill Financial Responsibility (OSFR) requirements and Qualification Records updates to the agencies before the compliance deadlines
Provides support to the Operations teams on agency inspections and through the resolution and closure of any Incidents of Non Compliance (INCs)
Coordinates incident reporting and investigation process for offshore related spills, releases and other incidents
Ensures Oil Spill Response Plan is managed properly by conducting routine updates and required annual drills
In addition to the tasks outlined in this job description, you may be assigned other responsibilities as needed
Bachelor’s Degree in EH&S, Engineering Discipline or Science related
Minimum of 3 years’ experience in the Oil and Gas industry preferable Offshore
Awareness of regulatory and industry governance/guidance in the Gulf of Mexico
Working knowledge of BOEM, BSEE, USACE and USCG regulations
Experience working with Federal, State, and Local Regulatory Agencies on Offshore Permitting
Ability to engage with business leaders and governmental agencies
Established industry network
Ability to read, understand, and explain Piping and Instrumentation Diagrams (P&IDs), General Arrangement (GA) Drawings, various valve and piping schematics, subsea survey charts

Senior Regulatory & Compliance Specialist Resume Examples & Samples

Organizes and maintains department databases and files on integrated pharmacy legal subjects including pharmacy and agency licenses. Project management and other duties as assigned
Research complex legal issues and relevant topics relating to Premier’s integrated Pharmacy business operations and federal and state licensing matters; presents findings to legal team
Research, analyze, and update in-house legal team on federal and state laws, regulations, and policies relative to contract law and healthcare industry; presents findings to legal team
Drafts complex legal documents, communications and reports under in-house attorney supervision
High School Diploma and relevant work experience in the healthcare and/or pharmacy industry required
Bachelors degree in Business, healthcare, pharmacy or related field preferred
5 years related experience in healthcare or pharmacy field required
Corporate paralegal experience preferred
Experience evaluating information to determine compliance with standards, laws and regulations; Board of Pharmacy state licensing experience; HIPAA compliance experience, Pharmacy related experience required
Experience with Medicare licensing preferred
Certified Paralegal and Certified Legal Assistant (CLA) from the National Association of Legal Assistants (NALA) or Paralegal Certificate from ABA approved school required
Certifications like CSM, PMP, Org Change Mgmt, ITIL, Six Sigma are recognized preferred
Ability to use good judgment with a high level of discretion and confidentiality; weighing alternate actions and making proposals
Ability to work both independently and collaboratively with cross-functional teams
Project management and time management skills
Candidate must possess superior writing and proofreading skills and have strong analytical and organizational skills
Must be internet savvy and able to effectively identify and assimilate content for end-users; advanced Microsoft Office Suite user, to include Word, PowerPoint, Excel and Visio; Excellent client consultation and process management skills
Outstanding verbal and written communication skills to include: facilitating group discussions/presentations; and communicating complex and technical information in a clear, concise manner with all levels of leadership
Proven ability to provide outstanding customer service and a self-motivated problem solver

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