Director of Regulatory Affairs

Lumira Search is partnered with a well-established, globally recognized name in peripheral vascular devices to find its next Director of Regulatory Affairs. Our client has a strong international revenue base and a device portfolio that’s trusted by vascular surgeons worldwide, and they’re now looking for a regulatory leader to help drive the next phase of growth. This is a senior, high-visibility role reporting into regulatory leadership, with real ownership over strategy for a portfolio that includes stents, balloons, catheters, and closure devices. You’ll be the one steering these products through FDA and international approval, and you’ll be doing it inside a large, matrix organization. Responsibilities Own regulatory strategy for a portfolio of Class III peripheral vascular devices, from early development through post-market Lead the full regulatory pathway - PMA, 510(k), De Novo, and international submissions across major markets Build and maintain direct relationships with the relevant FDA review branches Guide the regulatory impact of design changes, post-market data, and lifecycle updates Requirements 8+ years in medical device regulatory affairs, with several years in a leadership capacity Direct experience taking Class III vascular devices through full regulatory approval, including PMA Established relationships with the relevant FDA branches Deep familiarity with international submissions (EU MDR, Health Canada, and other key markets) Strong grasp of design controls, risk management (ISO 14971), and quality systems (21 CFR 820 / ISO 13485) This is an opportunity to join a globally recognized, established leader in peripheral vascular with a high amount of responsibility and opportunity for growth. Open to candidates based anywhere in Minnesota,this is a hybrid role between your home office and the HQ. #J-18808-Ljbffr Lumira Search