What are the responsibilities and job description for the Senior Regulatory Affairs Specialist position at BioTalent?
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 :
