Senior Regulatory Affairs Resume Samples

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J Mitchell

Jany

Mitchell

8292 Schultz Field

Boston

+1 (555) 734 4399

8292 Schultz Field

Boston

Phone

p +1 (555) 734 4399

Experience Experience

New York, NY

Senior Regulatory Affairs Engineer

New York, NY

Gleichner-Runolfsdottir

New York, NY

Senior Regulatory Affairs Engineer

Supports and provides regulatory expertise to assigned medical device product development projects from initial kickoff to post marketing phase
Participate in regulatory process improvements work
Represent regulatory affairs in new product development as well as maintenance projects
Appreciate compliance work
Introduces regulatory methods/procedures that are new for the organization. Applies advanced regulatory process principles to multiple tasks
Supports pending domestic and international regulatory changes and executes quality plans to minimize impact
Provides the Regulatory assessment of Engineering Changes for medical device launch and sustaining activities

Dallas, TX

Senior Regulatory Affairs Program Manager

Dallas, TX

Heidenreich, O'Kon and Waters

Dallas, TX

Senior Regulatory Affairs Program Manager

Enhances and manages one or more medium-scale regulatory programs with generally-defined plans and delivery methodologies including continuous improvement activities and compliance related projects
Participates in establishing program objectives, timelines, milestones and budgets to achieve departmental and organizational objectives
Manage annual AOP forecasting for program
Recommends program decisions to management on processes related to new and changing regulations, guidance documents, enterprise policies, regulatory processes and product issues
Develop implementation plan, communicate and deploy program schedules to ensure timely completion
Influences across functions and businesses while balancing divergent objectives to gain cooperation of other functions on program objectives and execution plans on initiatives such as business development, major change projects, new product development, etc
Interface with a variety of management levels on significant matters, often requiring the coordination of activity across functional groups

present

Philadelphia, PA

Senior Regulatory Affairs Program Lead

Philadelphia, PA

Ullrich-Rosenbaum

present

Philadelphia, PA

Senior Regulatory Affairs Program Lead

present

Works with Management to ensure rapid and timely approval of new products and continued Regulatory support of marketed products
Assists in the development of best practices for Regulatory Affairs processes
Develops labeling specifications and approves proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations
Partners with other functions to define and obtain data to assist with regulatory submissions
Provide Regulatory Affairs support during internal and external audits
Provides solutions to extreme complex problems
Creates detailed Regulatory Plans

Education Education

Bachelor’s Degree in Science

Harvard University

Bachelor’s Degree in Science

Skills Skills

Excellent problem solving skills
Ability to mentor and lead problem solving
Ability to interpret authority regulations
Ability to work unsupervised under own initiative
Excellent communication skills
Supports pending domestic and international regulatory changes and executes quality plans to minimize impact
Supports Internal and External Quality Audits Supports Regulatory QMS procedure updates
Introduces regulatory methods/procedures that are new for the organization. Applies advanced regulatory process principles to multiple tasks
Provides the Regulatory assessment of Engineering Changes for medical device launch and sustaining activities
Formulates the solution for (technical) partial problems that cannot be found by combining previous experiences but by composing newly acquired regulatory knowledge

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Senior Regulatory Affairs Therapeutic Resume Examples & Samples

3+ years of related experience
Bachelor's Degree in a related field
Previous experience in the Pharmaceutical industry or in a Laboratory or Clinical Research position
Microsoft Office/Suite proficient
Excellent communication skills (written and verbal)
Strong attention to detail
Highly organized
Able to multitask efficiently and effectively
Degree in Life Sciences
Previous Regulatory Affairs experience

Senior Regulatory Affairs Therapeutic Resume Examples & Samples

Bachelor's Degree
3-5 years' experience in either the Pharmaceutical industry or a laboratory
Intermediate proficiency in Microsoft Office Suite
Commitment to quality of all assigned projects
Excellent written and verbal communication skills
Commitment to regulatory affairs profession
Regulatory Affairs experience

Senior Regulatory Affairs Program Lead Resume Examples & Samples

Writes, coordinates, compiles, and submits Regulatory documents to FDA, EU notified bodies, and other Regulatory Agencies, including EPA and International Authorities
Also includes the preparation of international documents, including Technical Files and Design Dossiers
Works with Management to ensure rapid and timely approval of new products and continued Regulatory support of marketed products
Creates detailed Regulatory Plans
Includes in-depth team involvement, including Core Team membership for complex projects
Evaluates proposed product modifications for Regulatory impact on a world-wide basis
Completes Regulatory Assessments as needed
Ensures compliance with regulatory agency regulations and interpretations
Ensures preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides
Prepares responses to regulatory agencies’ questions and other correspondence
Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines
Develops timelines for submissions under the direction of senior regulatory affairs staff
Provides solutions to extreme complex problems
Provides regulatory advice to project teams
A minimum of 6 years of related professional experience in an FDA regulated industry is required
A minimum of 2 years of regulatory affairs experience in the pharmaceutical or medical device industry is required, inclusive of writing, coordinating, compiling, and submitting regulatory documents to the FDA
Direct experience with PMA and EU Class III devices is desirable
Knowledge of international regulations is preferred
Excellent communication skills, both verbal and written is required
Must have good organizational skills, analytical thinking, problem solving and investigative skills
Proficiency in Microsoft Office and related applications is required
This position is located in Irvine, CA and will require up to 10% domestic travel

Senior Regulatory Affairs Program Lead Resume Examples & Samples

Represent regulatory affairs on product development teams by attending team meetings and providing the global regulatory plan, regulatory assessments and regulatory decisions
Prepare regulatory documentation for Synthes devices, including Design Dossier, Technical file as well as IDE, 510(k) and PMA documentation for submission to the Food and Drug Administration (FDA). This includes the resolution of regulatory issues and questions from regulatory agencies and Notified Bodies during the pre-market product development phase
Assist in the preparation of approval documents to support rest of world registrations. Additional activities may require notarization and legalization of documents, and requesting of Certificates to Foreign Government and Free Sale Certificates
Review engineering changes to currently marketed products and prepare internal regulatory assessments for documenting decisions to submit or not to submit in accordance with relevant regulations and guidance
Review product labeling and product support information for currently marketed products to ensure that product information and claims are consistent with relevant regulations and guidance
Assist with the maintenance of the regulatory database with accurate and current regulatory information
Maintain current knowledge to ensure compliance to the applicable regulatory and corporate standards/ requirements (FDA Quality System Regulations, European Quality Standards, ISO 9001/13485, MDD, CMDCAS/CMDR, etc.)
Attend conferences, seminars, professional meetings, and other public forums that are relevant to the regulatory interests of Synthes
Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times
Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer
BA/BS Degree preferred or equivalent
Six to eight years of relevant regulatory experience in medical devices
Knowledge of MDD/MDR and relevant guidance
Knowledge of U.S. FDA medical device regulations and guidance
Knowledge of orthopedic implants a plus
Excellent written and oral communication skills in English and German or English and French
Ability to handle multiple tasks and be detail oriented

Senior Regulatory Affairs & Pharmacovigilance Executive Resume Examples & Samples

Manage the compilation and preparation of regulatory documents, information, data technical files to support approvals for new product registration, renewals and changes (NDA and LCM licenses)
Review the content of submission package provided by HeadQuarters (HQ) according to local Health Authority (HA) requirements
Identify any necessary documentation for the submission to local HA and prepare the application form, as required, according to HA requirements
Perform submission to HAs
Support approval and post-approval activities and ensure Registration Information Management System (RIMS) update with approval information within agreed timeline
Handle HAs or agents’ requests and demands on quality, clinical and non-clinical information according to NNAS standards/SOPs
Ensure timely submission and follow-up of labelling variations to the local HAs, in cooperation with the key stakeholders
Maintain licence to operate in affiliate by timely management the renewals and LCM activities
Support to fulfil any post-approval commitments required by HAs
Update and maintain paper/electronic document archival systems
Coordinate actions effectively and proactively with other functions to support product launches, LCM activities and supply in due time
Perform key tasks identified as business critical for Regulatory, Quality and/or Pharmacovigilance functions in Malaysia and Singapore when required, in the absence of the responsible person. Key back-up areas are identified and reviewed periodically
Minimum 3 years experience in pharmaceutical industry, with minimum one year experience in RA associate or similar regulatory position
Advanced knowledge of pertinent local regulations required
Experience with regulatory intelligence activities and pharmaceutical registration databases is preferred
Knowledge of diabetes and diabetes management beneficial
Knowledge of other therapeutic areas and/or biotech products relevant to Novo Nordisk beneficial
Previous supervisory/management experience required depending on team size

Senior Regulatory Affairs Resume Examples & Samples

Prepare, review and file appropriate FDA premarket submission to ensure devices are commercially available in the U.S.: 510(k)s, pre-IDEs, IDEs, etc
Create regulatory dossiers, i.e. technical files or Design Dossier for CE Marking; generate STED to support business access to international markets
Maintain current knowledge of ISO 13485, FDA and Medical Device Directive, applicable regulations, guidance and standards applicable to company products
Responsible for monitoring the progress of clinical trials, regularly checking for compliance and progress via phone, e-mail and on-site visits where necessary
Maintain document control; including regulatory documents, quality agreements, QS policies and procedures, etc
Monitor corrective and preventive actions
Analyze data, assist with input and review documentation related to complaints, CAPAs, protocols, regulatory submissions, etc
Investigate customer complaints and non-conformance issues as directed by QA management
Develop quality policy and establish quality objectives
Provide resources necessary to maintain QMS
Conducts Periodic management Reviews and ensures that quality policy and procedures are enforced at all organizational levels
Maintain regulatory documentation as it relates to Customer Complaint Handling and Corrections & Removals
Knowledge and experience in gaining FDA clearance for Class II medical devices
A minimum of 4-5 years of regulatory affairs/Quality Assurance working experience, mainly for medical devices. Must have knowledge of U.S. and/or European/International regulations and standards
Experience in preparing regulatory submissions; Experience interacting with FDA and/or other regulatory agencies
Ability to develop strategic regulatory plans and to communicate these effectively within the relevant structures
Strong project management skills essential – able to work across functions and departments and sometimes across companies to co-ordinate and deliver to an agreed RA submission plan
~10%

Senior Regulatory Affairs Data Management Specialist Resume Examples & Samples

Usually works with minimum supervision having some latitude for independent action or decision, conferring with more senior and supervisory staff when indicated, and keeps supervisor regularly informed on status of work
Developing and applying basic knowledge and understanding of regulatory data, the information systems in which they are stored, processes and procedures
Project management, writing, coordination, and execution of regulatory data management items
Assisting in SOP development and review
Assisting in the creation and maintenance of regulatory data based upon product and information system changes
Providing regulatory data management input to new product development and product lifecycle planning
Evaluating regulatory data management impact of proposed changes to launched products
Determining and communicating regulatory data management requirements
Represent the Regulatory Affairs team on projects impacting regulatory affairs data management
Support review and approval of product labeling for accuracy of regulatory data attributes before release
Providing regulatory data management input for and appropriate follow-up to inspections and audits
Assisting in the development and implementation of SOPs and systems to track and manage product-associated regulatory data
Reviewing change management to determine the level of change and potential regulatory data management requirements
Identifying product-associated regulatory data problems and developing proposals for solutions
Advising responsible personnel on regulatory data management requirements
Monitoring impact of changing regulations on regulatory data management requirements
Identifying issues early in the product attribute data preparation process that could impact product launch
Compiling, preparing, reviewing and submitting regulatory data to authorities
Support the creation and maintenance of regulatory data in Enterprise Resource Planning (ERP), Product Lifecycle Management (PLM) systems and others as required
Support the creation, maintenance and submission of regulatory data to comply with global Unique Device Identifier requirements
Generate, compile and communicate divisional performance and product trending metrics
Knowledge of the Quality System Regulations (21 CFR) and Medical Device Directives (MDD) in regarding to regulatory data management
Knowledge of ERP and PLM database systems
Mastery of Microsoft Excel
1-3 years IS experience
Effective interpersonal communication skills
Advanced PC skills
Previous experience in Information Systems (IS), database administration, or help desk environment

Senior Regulatory Affairs Office Resume Examples & Samples

Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters, including salary administration
Responsible for performance (quality, profitability, utilisation) of direct reports, ensuring consistent regulatory support, in accordance with Global Regulatory Affairs business plans. Ensures objectives of individual staff and teams are in line with overall Regulatory Affairs objectives by facilitating regular communications
Participate in the selection and on-boarding process for new Regulatory staff by conducting candidate review and participating in the interview process. Ensure staff have the appropriate materials, systems access and training to complete job responsibilities
May prepare a single service regulatory or technical proposal for senior review and/or propose budgets for less routine projects, out of scope activities and potential budget efficiencies. Deliver business development presentations to customers with confidence and detailed knowledge, as directed
Ensures compliance with regulatory processes, ensuring readiness for internal or external project audits
May represent region or site on a regulatory, technical or cross-functional Initiative
Demonstrate success in leading teams or previous experience in a supervisory capacity
Advanced negotiating and influencing skills and the ability to identify and resolve issues, using flexible adaptable approach. Remains calm, assertive and diplomatic in challenging interactions with customers
Understands and promotes Corporate and Global Regulatory Affairs Business Unit strategies, communicating this in a positive manner to staff
Ability to provide fair, timely, appropriate and constructive feedback and guidance to staff
Ability to earn trust of staff, acting in confidence and with sensitivity when dealing with personnel issues, staff expectations and conflict management
Strong software and computer skills, including MS Office applications

Future Senior Regulatory Affairs Engineer Opportunities Resume Examples & Samples

Support product engineering and manufacturing teams on regulatory issues, including review of design input, risk management and test documentation
Assess the impact of the product/process changes and determine regulatory pathway for US, EU and Canadian markets
Prepare and submit regulatory filings for the above markets including 510(k)s, Non-filling justifications, Technical File updates, Canadian License Applications
Work with other international regulatory counterparts to coordinate global regulatory submissions/approvals
Provide oversight of third party agency testing (UL, EMC, biocompatibility, sterilization assurance) as required
B.S. or higher in Biomedical Engineering, Electrical Engineering or Mechanical Engineering preferred
Non-technical degree with equivalent complex medical device experience acceptable
8 years relevant experience working in a medical device company
6 years of experience in regulatory submissions and technical documentation for a medical device company
Experience working with cross-functions teams including engineering, manufacturing, regulatory, quality etc
In-depth understanding of FDA, CE mark and Health Canada regulations
Ability to work with cross function project teams and understand complex products
Ability to work in a fast paced environment and handle multiple projects simultaneously
Strong verbal and written communication skills, proven ability to translate technical documentation into effective regulatory submissions
Ability to review and provide critical feedback on design documentation
Able to learn internal procedures and processes and implement the same on project teams
Good interpersonal skills and project management skills

Senior Regulatory Affairs Program Lead Resume Examples & Samples

Leads the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers
Guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials
Defines data and information needed for regulatory approvals
Develops labeling specifications and approves proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations
Provide Regulatory Affairs support during internal and external audits
Plans schedules for regulatory deliverables on a project and monitors project through completion
Assists in the development of best practices for Regulatory Affairs processes
Represents Regulatory Affairs on cross-functional project teams
Partners with other functions to define and obtain data to assist with regulatory submissions
Excellent written, verbal communication and presentation skills
Leverages a deep scientific and technical understanding of regulated products under scope of responsibility to provide strategic guidance and support for product development and life-cycle management of products
Integrates and executes results-oriented Regulatory Affairs strategies that are aligned with organizational objectives. Takes accountability for the achievement of business goals and objectives
Tactical and strategic regulatory knowledge necessary to gain approval and ensure maintenance of legal marketing status of all products, including Class III devices (especially EU)
Ability to partner and influence key stakeholders on NPD and Lifecycle teams
Clearly defines and prioritizes decision criteria and considers benefits, risks, and Credo of each alternative before making decisions. Considers all of the available facts when situations are ambiguous in order to make the best possible decision (for example, when regulations are unclear)
Consistently manages large amounts of changing, complex, and/or ambiguous information from multiple sources and makes timely and effective decisions for the execution of project objectives
Knowledgeable in US, EU and International Regulations
A minimum of a Bachelor’s degree from accredited college or university is required. A degree focused in science, biomedical engineering, medical/ scientific writing, public health administration preferred
6 years working in regulated healthcare industry is required. Medical device experience preferred
Experience in the preparation, and submission of US Regulatory files (510(k)s, PMAs) and/or European technical files and design dossiers is required
Knowledge of US, EU and International Regulations required. Knowledge of International Regulations in China, Japan, Brazil and Russia preferred
Experience with Medical Device Navigation Software and Instruments and/or Medical Device Software is preferred
This position is located in Raynham, MA and may require approximately 10% travel.Regulatory Affairs

Senior Regulatory Affairs & Export Control Specialist Resume Examples & Samples

You coordinate every necessary activities for preparation and evaluation of registrations dossiers and legal documents associated, and to direct and coordinate regulatory activities related to preparation of files for the new products registration processes, modifications, renewals and technical evaluations requirements for registration of products in the countries where they are needed; asking Global Regulatory support, preparing and sending required documents and giving support to local organizations for registration processes, negotiating with authorities any problem related with registrations in process, to obtain the approval for initiate or continue the products commercialization
You participate together or in consultation with the Regulatory Affairs Manager in local legislation and standardization, and to negotiate with in charge authorities the regulatory affairs that guarantee the establishment of an adequate regulatory environment for products to facilitate business growth and clearer communication in processes with authorities, in countries of regions where it applies
You represent the company with local authorities and associations in affairs related to current legislation (product launching, regulatory activities, quality affairs, etc.)
You monitor the legal and regulatory developments, changes or implementations in the countries of the region
You establish and maintain contact with regulatory authorities
You direct, compile, evaluate and notify involved departments about reports of adverse incidents received through Global Regulatory. To evaluate and notify about adverse incidents that should be notified to the authority according to current legislation
You actively support local organizations and marketing, sales and logistic departments to obtain documents related with regulatory affairs such as certificates, declarations, etc., needed ad required for tender processes, contracts and /or any commercial activity
You define, implement and monitor a follow up system for all registers of the region
You generate the reports required by the company regarding the areas under his/her responsibility
You perform other functions according to the requirements of the immediate Superior
You collaborate closely with the Legal, sales and Regulatory Affairs Manager in any projects or activities that the department requires
You will be backup for the Regulatory Affairs Manager in all Regulatory Affairs and Export Control matters

Senior Regulatory Affairs & Quality Manager Resume Examples & Samples

Plan and carry out drug registration activities
Ensure complete records/files of all product dossiers and updates submitted and approved by the regulatory authorities are maintained and archived including on-line submissions
Manage the Import License and associated Product List with timely updates for additions/changes
Review of promotional materials for regulatory compliance
Provide business-related support on regulatory activities, regulatory intelligence, complaints on competitors, Special Permit applications, etc
Handle pack management activities, including compliance to Local Labelling Requirements and processing pack changes when required
To manage product information updates with respect to Roche and local regulatory requirements and for Roche databases
To liaise closely with Regulatory Authorities and Professional Bodies and foster good rapport with them
To be responsible as Company Pharmacist

Senior Regulatory Affairs Product Specialist Resume Examples & Samples

Serve as the Regulatory representative on cross-functional teams supporting products throughout the stages of development and commercialization
Perform regulatory assessment on all proposed change control; gather required data as needed to defend a Regulatory filing strategy; coordinate and prepare post-approval supplements if warranted
Manage, prepare, publish using eCTD software well-organized, scientifically sound CMC and safety-related regulatory submissions which include ANDAs, Amendments, Annual reports, PSUR and Supplements that comply with applicable regulatory requirements in eCTD format
Coordinate and communicate timelines and deliverables with Regulatory Operations, Labeling and other key departments to facilitate quality CMC and safety-related regulatory submissions, including ANDAs, Amendments, Annual reports, PSUR and post approval Supplements
Review technical reports, summary documents and change controls (chemistry, manufacturing and analytical controls) for appropriate content and justifications as well as for adherence to regulatory guidelines, strategies, and commitments
Work with partners to create product labeling compliant with FDA, and compendial requirements for drug products
Contact FDA and other Regulatory authorities for review status updates for pending applications and supplements
Hands on experience in leading a variety of Regulatory submission activities (ANDAs, Post Approval Supplements, PSURs, Annual Reports.)
Familiar with a variety of pharmaceutical concepts, practices and procedures and the functioning of a regulatory affairs department
Ability to interpret Regulatory Authority policies and CMC guidance and correctly apply them as appropriate throughout the product life-cycle
Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data
Ability to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks
Familiarity with Trackwise
Ability to manage a variety of assignments
Detail oriented and highly organized
Strong interpersonal skills and ability to deal effectively with a variety of personnel including senior management

Senior Regulatory Affairs Executive Resume Examples & Samples

Excellent planning, time management and organisational skills
First class communication skills, both written and verbal
Knowledge of EU, UK and Ireland regulatory requirements
Strong influencing and negotiation skills with evidence of effective cross functional working
Driven and capable of delivering results efficiently and effectively
LI-PD2-EUR

Senior Regulatory Affairs Program Lead Resume Examples & Samples

Bachelor degree from accredited college or university in science, biomedical engineering, medical/scientific writing, public health administration is required
A minimum of 6 years regulatory affairs or related/equivalent experience is required
RAC (Regulatory Affairs Certification) by Regulatory Affairs Professional Society is strongly preferred
Leads the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers is required
Develops labeling specifications and approves proposed labeling and packaging, after evaluating conformance to regulations is required
Partners with other functions to define and obtain data to assist with regulatory submissions is required
Plans schedules for regulatory deliverables on a project and monitors project through completion is required
Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines is preferred
Provides solutions to extreme complex problems in which data analysis requires an evaluation of intangible variables is preferred1099170515

Senior Regulatory Affairs Training Manager Resume Examples & Samples

Identifying, developing, training and tracking of training to all Regulatory Affairs employees
Overseeing the lifecycle of training programs from the identification of training needs, content development, updates including version control and change log maintenance
Collaborate with departmental subject matter experts in the design of new training materials and updates to existing content
Initiate 'Train the Trainer' programme and development materials
Represents Regulatory Affairs in internal/external audits
Promote training and development capabilities within the department and PPD as appropriate, and provide individual and group training consultation
Bachelor's degree or equivalent and relevant formal academic/ vocational qualification
Minimum 8 years in Regulatory Affairs
Minimum of 5 years of training or education experience
In some cases, a combination of performance, education and prior directly related experience may be considered as equivalent
Demonstrates strong knowledge of regulatory affairs and understands its role in the drug development/approval/life cycle process eg: clinical trials support,

Senior Regulatory Affairs Training Manager Resume Examples & Samples

Minimum 8 years in Regulatory Affairs. In some cases, a combination of performance, education and prior directly related experience may be considered as equivalent to the above requirements provided that the individual possesses the following knowledge, skills, and abilities to perform the job requirements satisfactorily
Demonstrates strong knowledge of regulatory affairs and understands its role in the drug development/approval/life cycle process eg: clinical trials support, preparation of marketing authorisations, life cycle management, regulatory intelligence and CMC
Able to define, develop and deliver a variety of RA training and development programs
Has thorough understanding of ICH/GCP guidelines and PPD procedural documents and regulatory requirements
Ability to lead and oversee the planning and logistics of functional training initiatives as needed in an efficient and cost- efficient approach
Demonstrates confident and engaging presentation skills
Advanced skills in using MS Word, Excel, PowerPoint

Senior Regulatory Affairs Engineer Resume Examples & Samples

Supports and provides regulatory expertise to assigned medical device product development projects from initial kickoff to post marketing phase
Creation and execution of Regulatory Strategies and Plans for assigned medical device products in the domestic and international markets, including assessments of the regulatory impact of changes to design, materials, labeling, software, and suppliers
Develops the standards strategy for medical devices and supports activities required to maintain regulatory compliance as new or revised versions of standards are released
Prepares and submits US FDA pre-sub, 510(k), and other product submissions according to FDA guidelines
Creates EU Technical File and Declaration of Conformity documents (MDD, RED, LVD, RoHS, etc.) and Canadian licensing submissions according to international guidelines
Maintains expertise in domestic and international regulations and standards, with a focus on assigned medical devices and regional focus on the US (FDA), EU (MDD), and CA (Health Canada)
Support the international regulatory specialist team with inputs, as needed, into the registration packages they prepare
Supports pending domestic and international regulatory changes and executes quality plans to minimize impact
Provides the Regulatory assessment of Engineering Changes for medical device launch and sustaining activities
Reviews and approves medical device labeling plans, instructions for use, labels, and marketing communications
Supports Internal and External Quality Audits Supports Regulatory QMS procedure updates

Senior Regulatory Affairs Engineer Resume Examples & Samples

Formulates the solution for (technical) partial problems that cannot be found by combining previous experiences but by composing newly acquired regulatory knowledge
May lead multi-disciplinary regulatory change projects, managing a number of people. Works independently and provides consultative advice within specific functional regulatory areas
Introduces regulatory methods/procedures that are new for the organization. Applies advanced regulatory process principles to multiple tasks
Proficient in regulatory area of specialization and contributes in other disciplines. Determines feasibility of regulatory concepts or projects. Has basic knowledge of related disciplines
Bachelor’s degree with 5+ years of related experience in regulatory affairs engineering; or a Master’s degree with 3+ years of related experience in regulatory affairs engineering

Senior Regulatory Affairs Program Manager Resume Examples & Samples

Enhances and manages one or more medium-scale regulatory programs with generally-defined plans and delivery methodologies including continuous improvement activities and compliance related projects
Participates in establishing program objectives, timelines, milestones and budgets to achieve departmental and organizational objectives
Recommends policies and procedures that affect regulatory programs
Recommends program decisions to management on processes related to new and changing regulations, guidance documents, enterprise policies, regulatory processes and product issues
Leads projects and develops sound regulatory strategies for long term registrations of new and modified medical devices
Influences across functions and businesses while balancing divergent objectives to gain cooperation of other functions on program objectives and execution plans on initiatives such as business development, major change projects, new product development, etc
Evaluates regulatory risks and opportunities with acquisitions/divestitures and assists with due diligence and post-acquisition assessments
Leads in the understanding and awareness of US, EU and other international regulatory requirements to ensure compliance. Disseminates and provides guidance and continuing education as applicable
Establishes daily tasks, metrics development and implementation where necessary for successful program execution
Interface with a variety of management levels on significant matters, often requiring the coordination of activity across functional groups
Prepares and provides guidance regarding required documentation (510(k)s, technical documentation files, dossiers) for domestic and foreign submissions and registrations
Reviews and approves engineering changes, device labeling and marketing materials for compliance with FDA submissions and applicable regulations
Supports IIA activity; working closely with Quality and ENT Medical Officer
Assists with audits and inspections, if required
Represents the company in key professional meetings, seminars and other relevant activities
Travel requirement: Less than 10%
Bachelor's degree required in a technical discipline
7+ years of related experience including broad multi-functional business experience along with 5+ years of project management experience, or
Masters degree and 5+ years of related experience including broad multi-functional business experience along with 3+ years of project management experience
Expert in the field of Regulations and Standards affecting the Medical Device Industry
Graduate degree in science, engineering, or law preferred
Demonstrated competencies in project management
Experience with 510(k) applications, IDEs, PMA or PMA supplements and US device regulations and/or experience with other international medical device regulations and submissions
Extensive experience with EU Medical Device Directive (MDD) 93/42/EEC and exposure to EU Medical Device Regulation (MDR) 2017/245
Experience in due-diligence evaluations of companies and/or product acquisitions
Knowledge of principles and requirements of promotion, advertising and labeling
Proven success with working and negotiating with people from various disciplines, organizations, and cultures
Ability to follow scientific arguments, identify regulatory scientific data needs, solve regulatory issues, and define regulatory strategy
Ability to work in a highly matrixed and geographically diverse business environment
Ability to work within a team and as an individual contributor and ability to mentor junior team members in a fast-paced, changing environment
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
Ability to work independently with no oversight
Ability to identify and solve problems in a strategic manner and to manage complex projects
Ability to be proactive and not reactive, to anticipate changing business and regulatory environments
The employee must frequently lift and/or move up to 10 pounds

Senior Regulatory Affairs Program Manager Resume Examples & Samples

Develop thorough understanding of EU MDR requirements as well as subsequent guidance documents and implementing acts and provide guidance to organization on interpretation and impact to business
Communicate effectively with Regulatory and cross-functional leadership to ensure clear expectations, demonstrate progress and identify issues
Lead recurring meetings with cross-functional team of SMEs
Partner with EU MDR leaders from other business unts/groups regarding common Medtronic interpretation and guidance, deliverables, pace and progress across the organization to ensure a harmonized approach for achieving compliance
Develop implementation plan, communicate and deploy program schedules to ensure timely completion
Define objectives and milestones for successful program execution
Define and report metrics (scorecards) on program progress, implementation and effectiveness; deliver management reporting and escalation when required
Lead program execution to enable results and maintain commitments, including escalation to management for resolution of non-standard solutions
Manage annual AOP forecasting for program
8+ years (with Bachelor’s) or 6+ years (with Master’s) of experience in Regulatory Affairs or other function familiar with technical files and medical device product development process
Knowledge of current European medical device directives (MDD/AIMDD) and CE mark process
Experience driving change management initiatives across an organization
Experience delivering presentations at senior management levels in an organization
Ability to work independently or collaboratively to determine and develop approaches to solutions with very little to no supervision or direction
Experience influencing stakeholders at multiple levels in an organization
Experience with MS Project, MS Excel, MS PowerPoint, MS Word

Senior Regulatory Affairs Engineer Resume Examples & Samples

Provide guidance on product regulation and translate into meaningful business requirements
Gain market access for our regulated products including submissions
Communicate with regional and business teams and prepare responses on all governing agency actions
Review promotional labeling
Represent regulatory affairs in new product development as well as maintenance projects
Participate in product release process
Participate in regulatory process improvements work
Ability to work unsupervised under own initiative
Ability to interpret authority regulations
Ability to mentor and lead problem solving
Appreciate compliance work
Appreciate the role as specialist