Job Summary
A diversified technology company has a current position open for a Remote Principal Medical Device Regulatory Affairs Engineer.
Core Responsibilities of this position include:
- Supporting and providing regulatory expertise to assigned medical devices
- Creating and executing complex Regulatory Strategies and Plans
- Developing the standards strategy for medical devices
Must meet the following requirements for consideration:
- Bachelor’s with 5+ years experience in regulatory affairs engineering or equivalent may be considered
- 3 years of experience in the medical device industry
- Experience with successful preparation and submission of 510(k), PMA, or international documents
- Experience in Design Controls
- Working knowledge of medical device regulations
- Experience in supporting international registrations and clinical investigations
