Regulatory Affairs/Quality Affairs Specialist

This role collaborates cross-functionally across the organization to prepare, submit, and maintain regulatory filings with agencies such as the U.S. FDA, European Notified Bodies, and other international authorities. The role involves ensuring the maintenance of regulatory files, declarations of conformity, and device listings/registrations are accurate and complete. The Specialist will also oversee inquiries into regulatory agency requests for additional information for document submission.

What You Will Do

Primary responsibilities include authoring and managing regulatory submissions, supporting U.S. and EU market approval processes, and ensuring compliance with regulatory standards. The role also involves analyzing and reporting post-market quality data/metrics and failure trends to identify safety signals.

Why It Might Be a Fit

The ideal candidate will have a strong understanding of FDA and EU medical device regulations, with hands-on experience in leading or partnering in CAPA, SOP, RMA, NCR, Safety Reporting, and investigations. The candidate should also have proficiency with PC systems and office applications, as well as strong organizational, communication, and planning skills.

Requirements

• Bachelor's degree in biomedical, RA/QA or related scientific area for medical device industry (RAC certification preferred)
• 3-5 years' experience in a regulated FDA environment (medical devices or combination products)
• Hands-on experience with 510(k) submissions (IDE and PMA knowledge a plus)
• Strong knowledge in regulatory strategy and approval approaches
• Hands on experience in leading or partnering in CAPA, SOP, RMA, NCR, Safety Reporting, and investigations
• Strong understanding of FDA and EU medical device regulations (international experience desirable)
• 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

Benefits

• Salary range is $75,000-$87,000/annual USD
• Employment offer based on candidate's professional experience, specialty, skillset, education, geography, related licenses or certifications, and other business needs