This is a hands-on regulatory role with meaningful ownership across submissions, compliance, and day-to-day regulatory operations. Even if hired at the Manager level, this role remains deeply involved in execution.

• 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

Qualifications: 

• 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

Hint for applicants: the answer to the mystery question is 23.

Company Overview & Disclaimer:

Lexington Medical, Inc. is a surgical stapling company based in Bedford, MA, developing smart surgical technology for minimally invasive procedures. We are not affiliated with Lexington Medical Center. We’re hiring top engineers and medical device sales professionals to help us grow and improve outcomes for patients worldwide.