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.

• 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

• 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.