Senior Regulatory Affairs Specialist Job Cambridge Massachusetts USA,Business

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 Med Tech 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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