Senior Regulatory Affairs Specialist

Pragmatic; Massachusetts; On-site; USD 100,000 - 130,000; Full time

Job summary

A MedTech company is seeking a Regulatory Affairs professional to lead PMA supplements and ensure compliance with FDA regulations. The role involves managing regulatory strategy for product changes and lifecycle management. Candidates should have over 5 years of experience in medical devices. This position is mostly on-site in Massachusetts with some flexibility for remote work on Fridays.

Qualifications

• 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.).

Responsibilities

• Leading PMA supplements and IDEs submissions.
• Owning regulatory strategy for product changes.
• Assessing complaint reportability and preparing reports.

Skills

Regulatory Affairs experience

Technical writing skills

Knowledge of FDA regulations

Project management

Job description

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.