Lexington

Compliance

• 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

Senior Regulatory Affairs Specialist – Senior IC or Manager