Job Summary
A diversified technology company is in need of a Remote Senior Medical Device Regulatory Affairs Engineer.
Candidates will be responsible for the following:
- Providing regulatory expertise to assigned medical device development
- Creating and executing complex Regulatory Strategies and Plans
- Developing the standards strategy for medical devices
Position Requirements Include:
- Degree with 3 - 5 years of experience, or equivalent combination of education and experience
- Knowledge in the area of FDA procedures and practices
- A working knowledge of medical device regulations
- Experience in the medical device industry
- Experience with FDA premarket notification submittals
- Experience interacting with FDA