Hybrid Senior Regulatory Affairs Specialist – Senior IC or Manager

at Lexington

• Job title: Senior Regulatory Affairs Specialist – Senior IC or Manager
• Job type: Full Time
• Experience level: Senior
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, United States

About the role

• Senior Regulatory Affairs professional leading global medical device regulatory strategy at Lexington Medical. Focused on enabling product development and regulatory compliance for surgical devices.

Responsibilities

• 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