What You’ll Do
- Leading PMA supplements, IDEs, and/or 510(k) submissions
- Owning regulatory strategy for product changes and lifecycle management
- Assessing complaint reportability and preparing adverse event reports
- Reviewing engineering changes and determining regulatory impact
- Supporting EU MDR Technical Documentation (if applicable)
- Partnering cross-functionally with R&D, Quality, Manufacturing, and Clinical
- Contributing to QMS maintenance and audit readiness
- Supporting regulatory implications of manufacturing changes or site transfers
This role requires sound regulatory judgment, strong technical writing skills, and the ability to manage multiple projects without heavy day-to-day direction.
What We’re Looking For
Required:
- 5+ years of Regulatory Affairs experience in medical devices
- Direct hands-on experience authoring and managing 510(k), PMA, and/or EU MDR submissions
- Strong knowledge of FDA regulations (21 CFR 820, 814, 803, etc.)
- Experience interacting with FDA (submissions, deficiency responses, meetings)
- Ability to independently manage regulatory projects
- Strong technical writing skills
Nice to Have:
- EU MDR Technical Documentation experience
- Experience supporting facility expansion or site transfer
- RAC certification
Why This Role
- Active PMA approval and ongoing lifecycle activity
- Commercial-stage MedTech environment
- High ownership and high visibility
- Direct cross-functional influence
- Opportunity to help build long-term regulatory infrastructure
Location & Work Model
- On-site role four (4) days per week in Bedford, MA
- Some flexibility for remote work on Fridays
- Occasional travel as needed
Interview Process
Selected candidates will be invited to complete a short one-way video interview , followed by virtual and on-site interviews with the team.
If you’re currently operating at a Senior level and ready for greater ownership — or already working at a Principal level and looking for real regulatory impact — this is a strong opportunity to step into a visible, commercially meaningful role.
If interested, apply directly or message me confidentially.
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