Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist (Senior IC or Manager) Lexington Medical, Inc. is hiring a Senior Regulatory Affairs professional to lead global medical device submissions and regulatory strategy. For candidates who are not local to the Boston area, this role can be remote with expectations to work primarily aligned with US East Coast business hours and be willing to travel periodically to Bedford, MA to spend time in‑person with colleagues. Company Overview Lexington Medical, Inc. is a medical device company designing and manufacturing advanced minimally invasive surgical stapling solutions. Based in the Boston area, we operate with a singular focus on engineering excellence, smart manufacturing, and rapid iteration. Our products are used globally in critical surgical procedures, and we compete in a $6B+ surgical stapler market dominated by legacy technology. Lexington is built for people who want to do meaningful, technically rigorous work in a high‑expectation environment. We value learning capacity, ownership, and sustained excellence. Role Overview This role reports to the Head of Regulatory Affairs and Quality and plays a central role in advancing Lexington Medical’s product pipeline and global footprint. We are seeking a Senior Regulatory Affairs professional to own and drive regulatory strategy for new product development and global expansion. This role is intentionally flexible in level. Title and compensation will be aligned accordingly, as we care more about capability and impact than tenure or titles. We are open to hiring either a Senior Individual Contributor or a Regulatory Affairs Manager. 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, ISO13485, and ISO14971. 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, ISO13485, and ISO14971. 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. SalaryRange: $115,000USD – $185,000USD Seniority level: Mid‑Senior; Employment type: Full‑time. #J-18808-Ljbffr