Job Summary
A technology company needs applicants for an opening for a Remote Senior Medical Device Regulatory Engineer.
Core Responsibilities of this position include:
- Creating and executing complex regulatory strategies and plans
- Preparing and submitting US FDA pre-sub, 510(k) and other product submissions
- Reviewing and approving product labeling plans, labeling, and marketing communications
Applicants must meet the following qualifications:
- Bachelor's or Master's degree, or a unique combination of education and experience
- Knowledge in the area of FDA procedures and practices
- Working knowledge of medical device regulations
- Experience in the medical device industry
- Basic knowledge of related disciplines
- Experience with FDA premarket notification submittals
