Lexington

Senior Regulatory Affairs Specialist – Senior IC or Manager

Lexington

full-time

Posted on:

Location Type: Hybrid

Location: Massachusetts • 🇺🇸 United States

Visit company website
✨ AI Apply
Apply

Job Level

Senior

About the role

  • Lead and author regulatory submissions for U.S. and international markets, including 510(k)s, EU MDR technical documentation, and design dossiers
  • Own regulatory strategy and execution for new product development programs from early concept through commercialization
  • Serve as the regulatory representative on cross-functional product development teams, ensuring regulatory requirements are integrated throughout the product lifecycle
  • Support ongoing regulatory compliance activities, including change order review, design change assessments, and maintenance of existing clearances and approvals
  • Review and approve product labeling, instructions for use, and related materials to ensure regulatory compliance
  • Maintain awareness of evolving global regulations, standards, and guidance, including FDA requirements, EU MDR, MDSAP, ISO 13485, and ISO 14971
  • Participate directly in regulatory correspondence and interactions with regulatory authorities such as the FDA and Notified Bodies
  • Partner closely with Quality, Manufacturing, and Commercial teams to support audits, inspections, and day-to-day regulatory operations

Requirements

  • Bachelor’s degree in Engineering, Science, Regulatory Affairs, or a related technical field
  • Typically 5–15+ years of experience in medical device regulatory affairs
  • Demonstrated ownership of FDA submissions as well as EU technical documentation
  • Extensive experience with post-market surveillance, including complaint handling support, vigilance reporting, trending, and regulatory maintenance activities
  • Experience with complex medical devices, including electromechanical systems and software-enabled products
  • Working knowledge of international regulatory frameworks and standards, including EU MDR, MDSAP, ISO 13485, and ISO 14971
  • Strong written and verbal communication skills and the ability to influence cross-functional teams
  • High attention to detail combined with sound judgment and the ability to manage multiple priorities in a fast-paced environment
  • Ability to operate independently while partnering closely with engineering, quality, manufacturing, and commercial teams
  • RAC certification is a plus, but not required.
Benefits
  • Travel occasionally to Bedford, MA to spend time in-person with colleagues

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
regulatory submissions510(k)EU MDR technical documentationdesign dossierspost-market surveillancecomplaint handlingvigilance reportingregulatory maintenanceelectromechanical systemssoftware-enabled products
Soft skills
strong written communicationstrong verbal communicationinfluence cross-functional teamshigh attention to detailsound judgmentmanage multiple prioritiesoperate independentlypartnering with teams
Certifications
Bachelor’s degreeRAC certification