Job Summary
A science and technology innovator has an open position for a Remote Staff Regulatory Affairs Specialist.
Individual must be able to fulfill the following responsibilities:
- Author global pre-market submissions, including 510(k)s and PMA supplements to the U.S. FDA
- Create and manage Technical Files in compliance with IVDD and IVDR
- Advise business teams to consider the impact of current or emerging regulatory issues,
Skills and Requirements Include:
- Bachelor's Degree with 9+ years of experience in Life Sciences
- Subject matter expertise in registration and commercialization of medical devices, including 510(k) to the FDA
- Demonstrated experience developing effective pre-market regulatory strategies
