Regulatory Affairs Specialist

What You’ll Do

As a Regulatory Specialist, you will support regulatory activities across the full product lifecycle, including:

• Supporting U.S. regulatory submissions (510(k), IDE, PMA support activities)
• Developing and maintaining EU MDR Technical Documentation
• Maintaining device registrations and listings
• Assessing complaint reportability and preparing adverse event reports
• Reviewing engineering change orders and assessing regulatory impact
• Supporting standards compliance and regulatory surveillance activities
• Acting as a regulatory representative on cross-functional product teams
• Supporting QMS maintenance and internal / supplier audits
• Maintaining accurate regulatory files and documentation
• This is a hands-on regulatory role
  , not a purely administrative position.

Required:

• Bachelor’s degree in a scientific or engineering discipline (biology, chemistry, biomedical engineering, etc.)
• 1–3+ years of Regulatory Affairs experience in medical devices
• Hands-on exposure to FDA and/or EU regulatory submissions
• Working knowledge of FDA regulations and/or EU MDR
• Strong technical writing and documentation skills
• Comfortable working cross-functionally with engineering and quality teams
• Detail-oriented, organized, and willing to speak up when something doesn’t look right

• Experience with EU MDR Technical Documentation
• Exposure to 510(k), IDE, or PMA submissions
• RAC certification or interest in pursuing it

• Join a company moving from clinical-stage to commercial
• Gain meaningful ownership early in your regulatory career
• Work closely with experienced regulatory leadership
• Build depth across U.S. and EU regulatory pathways
• Be part of a collaborative, pragmatic team environment

• On-site role four (4) days per week in Bedford, MA
• Some flexibility for remote work on Fridays
• Occasional travel as needed

Selected candidates will be invited to complete a short one-way video interview
, followed by virtual and on-site interviews with the team.