Head of Regulatory Affairs
Remedy RoboticsSan Francisco, California, United States
Posted May 19, 2026
Full Time
About the Company
Remedy Robotics aims to bring state-of-the-art vascular intervention to anyone, anytime, regardless of their location.
Job Description
Remedy Robotics is looking for a Head of Regulatory Affairs to lead the regulatory strategy and FDA-facing voice for their semi-autonomous endovascular surgical robot. The role involves owning the regulatory roadmap, authoring submissions, and partnering with cross-functional teams to land an autonomous Class III surgical device with the FDA.
Requirements
- 10+ years in regulatory affairs at medical device companies
- Experience leading a Class III device through FDA submission (IDE → PMA or De Novo)
- Strong working knowledge of 21 CFR Parts 812, 814, and 820; ISO 13485; ISO 14971
- Experience with FDA AI/ML device guidance and the Predetermined Change Control Plan framework
- Demonstrated success running pre-submission (Q-Sub) meetings and managing ongoing FDA correspondence
Benefits
- Generous Paid Time Off
- 401k Matching
- Retirement Plan
- Health Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- Stock Options
