Director of Regulatory Affairs

Senior Director, Regulatory Affairs | Class III Implantable $200,000 -$250,000 + bonus/equity I’m supporting a pioneering MedTech company developing a complex, software-driven implantable device. They need a hands‑on regulatory leader to own US strategy for a new platform and lead the programme through FDA approval. You: Led an original IDE submission Led an original PMA submission Class III active implantable device experience, ideally neuro or cardiac Experience with a complex system combining mechanical, electrical, software and firmware components Strong track record of independent FDA interaction Start-up or small-company experience Comfortable working through changing priorities, ambiguity and uncertainty Able to work onsite in San Diego five days per week The role will cover: Regulatory strategy for new product development IDE, PMA and subsequent supplement submissions Software, firmware and AI/ML regulatory considerations FDA meetings and agency correspondence Design changes, manufacturing changes and design transfer Close partnership with R&D, engineering, quality and clinical teams You’ll need 12+ years in medical-device regulatory affairs and the credibility to operate strategically while remaining close to the submissions. If you have personally taken an original IDE and PMA through the FDA or know somebody who has message me directly for a confidential discussion. #J-18808-Ljbffr Connect Life Science