Regulatory Affairs Specialist

Regulatory Affairs Specialist

This role collaborates cross-functionally with Quality, Engineering, Clinical, and Manufacturing teams to prepare, submit, and maintain regulatory filings with agencies such as the U.S. FDA, European Notified Bodies, and other international authorities.

Key Responsibilities

• Assist in the preparation, formatting, and collection of regulatory submissions
• Ensure the maintenance of regulatory files, declarations of conformity, and device listings/registrations are accurate and complete.
• Oversee inquiries into regulatory agency requests for additional information for document submission.
• Support U.S. and EU market approval processes and ensure compliance with regulatory standards
• Support post-market submissions (progress reports, annual reports, etc.)
• Provide regulatory assessments for marketing, R&D, and manufacturing changes or product transfers.
• Communicate with distributors in response to requests for information, regulatory inquiries or in support of regulatory filings.

Compliance & Quality System Support

• Partner with Quality Assurance to ensure continued compliance with applicable regulatory standards, including FDA 21 CFR 820, ISO 13485, and EU MDR 2017/745.
• Support in audits (internal and external) in document preparation as needed.
• Support document control and recordkeeping to ensure regulatory documentation integrity and traceability.
• Assist in preparing regulatory applications that are compliant with applicable regulatory requirements to achieve business objectives.

Cross-Functional Collaboration

• Partner with Engineering and Clinical teams to gather information needed for submissions and documentation.
• Assist in preparing summaries, tracking deliverables, and ensuring timely submission of regulatory documents.
• Support training and awareness initiatives related to regulatory compliance.
• Interpret new or existing regulations and ensure business practices align with compliance requirements.
• Create documentation in response to customer regulatory requests which includes regulatory letters, authorization letters, certifications, attestations, technical packages, etc. for tenders and for pre-market clearance.
• Clearly and effectively communicate team/project progress/status, decisions, timelines, etc. to other teams/departments and executive leadership.
• Establish and maintain regulatory information systems.
• Contribute in continuous improvement initiatives and process optimization within Regulatory Affairs.

Qualifications:

• Bachelor's degree in biomedical, RA/QA or related scientific area for medical device industry (RAC certification preferred).
• Master's degree in related field can count towards 1 year of relevant experience.
• 3-5 years of experience in a regulated FDA environment (medical device industry experience required).
• Hands-on experience with 510(k) submissions (IDE and PMA knowledge a plus). Strong knowledge in regulatory strategy and approval approaches.
• Working knowledge of FDA, EU MDR, or ISO regulatory environments preferred.
• Audit experience as a contributor is preferred.
• Ability to efficiently navigate through the regulatory process either individually or in a team setting ensuring a project's success.
• Strong organizational, communication (verbal and written), and planning skills.
• Ability to interact cross functionally across multiple departments with various levels of the organization.
• Detail oriented, practical and proactive problem solver.
• Proficiency with PC systems and office applications.
• Solid understanding of scientific principles applied to regulatory affairs.
• Understanding of regulatory and business needs with ability to engage cross functional team members.

Salary range is $75,000- $85,000/annual USD An employment offer is based on the candidate's professional experience, specialty, skillset, education, geography, related licenses or certifications, and other business needs. The compensation range indicated does not include other forms of compensation or benefits. We value the diversity of our team and inspire creativity in our innovation. elliquence proudly provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any kind without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state and local laws. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If you need any reasonable accommodation due to a disability for any part of the application process, please email View email address on click.appcast.io.