What are the responsibilities and job description for the Senior/Principal Regulatory Affairs Specialist position at Med Device QA?
Senior/Principal Regulatory Affairs Specialist (position level dependent on amount of experience)
Required Experience
- 4 years of Regulatory Affairs experience in medical device
- Experience authoring/supporting 510(k) or PMA submissions
- Experience with Design Controls
Nice to Have Experience
- EU MDR Regulatory Affairs experience with CE Marking/Technical Files
- Experience with either cardiac/cardiovascular medical devices or experience with medical device capital equipment
- Regulatory Affairs experience with medical device software (IEC 62304)
**Local Candidates Strongly Preferred. This is a onsite/hybrid position with at least 3-4 days onsite. If not local, must be willing to relocate/commute**
Salary : $120,000 - $175,000