Position Summary:

We are partnered with a class II device manufacturer to seek a Senior Regulatory Affairs Specialist to join their team. This is a hybrid opportunity to work on next-gen technology in the medical device space. Keys for this role will be complex device experience as well as global regulatory submission experience.

Key Responsibilities:

• Develop and execute regulatory strategies to support product registration and market access in domestic and international markets.
• Prepare, compile, and submit regulatory documentation, including 510(k) submissions, Technical Files, CE Marking, and international dossiers (e.g., Canada, EU, APAC, LATAM).
• Maintain current knowledge of global regulatory requirements, including FDA, EU MDR/IVDR, ISO standards, and other regional regulations.
• Provide regulatory guidance during product development, risk assessments, and design reviews to ensure compliance.
• Act as the primary contact for regulatory agencies, responding to inquiries, audits, and inspections.
• Assist in developing and maintaining quality systems and processes in compliance with ISO 13485 and FDA QSR requirements.
• Mentor and guide junior regulatory staff, providing expertise and support as needed.

Qualifications:

• 5+ years of experience in regulatory affairs within the medical device industry.
• Strong knowledge of FDA regulations, EU MDR/IVDR, ISO 13485, and other applicable standards and guidelines.
• Experience with regulatory submissions, including 510(k), PMA, De Novo, or equivalent international filings.
• RAC (Regulatory Affairs Certification) or Masters in RA is a plus.