Regulatory Specialist Job Description
Regulatory specialist
provides interpretation of regulations and regulatory rules/guidelines to demonstrate Medical Affairs and its delegated entities comply with state and federal standards.
Regulatory Specialist Duties & Responsibilities
To write an effective regulatory specialist job description, begin by listing detailed duties, responsibilities and expectations. We have included regulatory specialist job description templates that you can modify and use.
Sample responsibilities for this position include:
Provide advice on regulatory affairs requirements for all proposed changes to device design
Act as regulatory affairs representative on product design and R&D redevelopment teams
Assists attorneys in developing, researching and revising customer-facing messaging on escalated regulatory topics for use by regulatory affairs and other internal groups
Ensuring continuous compliance
Compilation of regulatory submissionsLeading the preparation and direct all activities for inspection/audits and follow through on close out of any subsequent actions assigned
Support other Lake Region sites with any queries relating to New Ross site that may arise during their audits
Review current technical product files for compliance to international requirements.Answer all customer regulatory requests and complaints
Design and implementing quality systems improvements
Support plant validation documentation programs as required, ensuring records are maintained
Responsible for timely preparation of submissions to Regulatory and Consumer Agencies
Regulatory Specialist Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Regulatory Specialist
List any licenses or certifications required by the position: RAC, ASQ, US, RAPS, DSP, ETL, UL, RA, ISO, TSCA
Education for Regulatory Specialist
Typically a job would require a certain level of education.
Employers hiring for the regulatory specialist job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Associate Degree in Science, Education, Chemistry, Engineering, Technical, Business, Medical, Biology, Pharmacy, Sciences
Skills for Regulatory Specialist
Desired skills for regulatory specialist include:
Local regulatory requirements/guidelines
Techniques for handling complaints and dealing with the public
Understanding of the overall drug development process
Good Clinical Practice
Federal
Regulations
IRB review and approval process
Regulatory affairs
State
Rules
Desired experience for regulatory specialist includes:
Competent in preparing written communication and correspondence
Ability to make verbal presentations and effectively negotiate with regulatory, technical, medical and legal professionals
Comprehension of engineering principles adequate to allow participation in New Products Development and field complaint issues
Bachelors' degree in Biological Science, Social Sciences, English, or other related field
Computer skills and Microsoft Office skills (Outlook email, Word, Excel, Power Point) required
Minimum 5-7 years in the Medical Device Industry with at least 3 years working directly with management of change and/or Design History File creation/maintenance
Regulatory Specialist Examples
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Regulatory Specialist Job Description
Job Description Example
Our innovative and growing company is looking to fill the role of regulatory specialist. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for regulatory specialist
- Build and support strong partnership with Regulatory authorities
- Interpret, translate, explain and provide applicable, accurate, and appropriate information with respect to products and services, equipment, policy and procedure, account status, marketing promotions and campaigns, serviceability, and service problems
- Take appropriate ownership and accountability of customer issues and concerns, including responsible escalations, in order to facilitate successful outcomes and minimize the need for future contacts
- Build and support strong internal and external partnerships with other organizations to resolve complaints from regulatory and consumer agencies
- Eliminate repetitive occurrences of customer dissatisfaction through reporting of data, trend analysis and identification of business improvement opportunities
- Strong analytical skills, strong written and verbal communication skills
- Organize and maintain regulatory files with this information to ensure accessibility for external agencies
- Determine US regulatory status of product ingredients
- Develop US product labeling, including supplement and drug facts
- Develop finished product dossiers
Qualifications for regulatory specialist
- Willingness to obtain FINRA licensing (Series 7)
- University degree in Business, Finance, Accounting or a related field an asset
- A minimum of 5 years’ experience within the Fund Valuations, Compliance, Legal, or Product Development department of a financial services provider
- Autonomous with demonstrated ability to work under pressure
- Familiarity with processes supporting the development, production, and implementation of Forms/Regulatory projects or printed materials and ability to work with and negotiate with external agencies and production suppliers
- Knowledge of MS-Office tools (e.g., Excel, Word, PowerPoint, Project) essential
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Regulatory Specialist Job Description
Job Description Example
Our innovative and growing company is hiring for a regulatory specialist. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for regulatory specialist
- Act as regulatory project team member providing review and approval of project documentation deliverables while applying various regulations and regulatory guidelines
- Maintain and update liquids and illiquid's legal entity database
- Respond to written regulatory inquiries from the SEC (Securities Exchange Commission), NFA (National Futures Association)
- Ability to interact with all levels of internal and external management in a consultative matter
- Layout and desktop publishing, to ensure that design drafts are returned in an accurate and timely manner
- Blueprint approval
- Stakeholder sign-off, to ensure that all affected parties have received a chance to comment on projects while in development and that their comments and approval have been retained for audit purposes
- Printing and delivery, to ensure that adequate quantity is produced to meet near-term demand and prevent wastage
- Project notification, to ensure that management and other interested parties are kept informed of the status of projects throughout their lifecycles
- Inventory monitoring, to ensure printed quantities are available at all times for use by sales channels
Qualifications for regulatory specialist
- Experience with USA regulatory requirements would be advantageous
- Ability to multi-task, strong attention to detail, exceptional oral and written communication skills, and excellent problem-solving skills are essential for this position
- Strong interpersonal and communication skills (verbal and written) and the ability to use these skills to effectively interact with individuals at all levels of the organization ( external clients/vendors)
- Thorough with strong attention to detail
- Leadership/Leading Others
- Strong understanding of the risk environment
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Regulatory Specialist Job Description
Job Description Example
Our growing company is searching for experienced candidates for the position of regulatory specialist. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for regulatory specialist
- Research and assess Department orders other policy issues impacting the telecommunications and cable industries, including those addressed by our federal counterpart, the Federal Communications Commission
- Reconcile, review and record daily operation activities from clearing accounts such as BONY, Merrill, Goldman and Pershing related to match principal businesses
- Manage monthly reconciliation of trade volumes, forward settlements and mark to market of mortgage TBAs
- Act as Internal and external audit interface between Operations and Finance
- Review and maintain interface table to reflect new brokers, new desks and new products before the interface post to the Oracle GL
- Generate and distribute Daily Revenue Report which includes forecast or budget and extrapolated actual revenues
- Assist in other ad hoc management reporting tasks
- File required submissions with appropriate regulatory agency
- Providing some day-to-day direction to junior staff including cross training and development
- Participating in the Regulatory and Financial Audits
Qualifications for regulatory specialist
- Conduct modeling of compensation plans (for EMEA or other business areas) to determine financial impact to the business
- Utilize compensation systems and participate in projects to implement or enhance existing compensation program administration
- Participate in the submission of data to a variety of compensation surveys
- Requires some travel within Continental Europe to the U.S
- Previous analytical role in compensation or related field (finance, compliance, legal, ) required
- Previous experience in asset management, banking or consulting, strongly preferred
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Regulatory Specialist Job Description
Job Description Example
Our company is looking to fill the role of regulatory specialist. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for regulatory specialist
- Manage and oversee new study initiation process, including educating study staff and sponsors, resolving issues and providing regulatory guidance and support
- Facilitate and participate in committee meetings, ensure procedures are followed
- Revise submissions for identified problems and issues and resolve any procedural issues that might arise in order to ensure timely response
- Maintain regulatory documents, monitor and recommend improvements for tracking regulatory documents
- Provide guidance to project team members specific to regulatory compliance
- Deliver GCP training to corporate headquarters
- Provide guidance to cross-functional project teams regarding application of medical device labeling requirements during Regulatory review and approval of product labels and instructions for use
- Provide advisement to OEM customers regarding product registration requirements, various aspects of the product development process product label and IFU development for OEM projects
- Balance and maintain priorities in fast-paced changing work environment
- Maintain positive communication with cross-functional team members OEM customers
Qualifications for regulatory specialist
- Knowledge of Broker Dealer activities, Bloomberg terminal and Hyperion
- Masters Degree and 3 years of directly related experience or
- Degree in Life Sciences discipline
- Co-ordinate and review the external regulatory returns produced in the UK, the UK consolidated entity’s Pillar 3 Report, and internal reporting to senior management in the UK
- Support the delivery of regulatory reporting for the Group entities across the wider EMEA region
- Prepare analysis to support the ICAAP process, particularly with regard to stress testing
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Regulatory Specialist Job Description
Job Description Example
Our innovative and growing company is hiring for a regulatory specialist. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for regulatory specialist
- Keeps apprised of new regulations, standards, policies, and guidance issued by relevant regulatory authorities that may impact the company
- Be effective with remote team meeting participation and communication
- Assures full regulatory compliance of all documentation for submissions and change management
- Provides guidance for the interpretation and applicability of requirements
- Assures claims and documentation are supported by objective evidence and data on file, for regulatory coverage held or sought
- Serves as a lead regulatory representative on the cross-functional teams, as assigned
- Assures claims and submissions
- Review service provider notices, bills, practices, rates and tariffs in accordance with Department requirements
- Respond to incoming telephone calls, emails, written correspondence and in-person communications from the general public concerning industry related issues
- Investigate and resolve consumer-related disputes with telecommunications and cable providers, including but not limited to, determining relevant facts, analyzing complaint related documentation and drafting correspondence to both service providers and consumers
Qualifications for regulatory specialist
- Review consultation papers and statements issued by the FCA and other relevant bodies and determine firm policy for regulatory reporting
- Develop relationships with internal stakeholders (Business, Finance, Risk, Legal & Compliance) and become established as an SME for regulatory issues
- Several years of regulatory experience acquired within investment management, banking, or an advisory firm
- Prior experience of preparing FSA returns under BIPRU
- Proficient in Excel (macros, pivots)
- Ability to effectively present information and respond to inquiries from employees, regulatory agencies, and others, as necessary