- Robot type
- Surgical and Medical
- Location
- San FranciscoCaliforniaUSA
- Job type
- Business Operations
- Posted
- May 19, 2026
- Salary
- $220,000–$280,000 a year
Full-time
Head of Regulatory Affairs
Job description
We are looking to hire a Head of Regulatory Affairs for our Clinical/Regulations Team.
Remedy Robotics is a medical technology company developing robotic systems for endovascular intervention. Its proprietary technology combines robotics, machine learning, and advanced computer vision to help physicians perform highly precise endovascular procedures and expand access to life-saving stroke and cardiovascular care. Initially focused on neurovascular intervention, Remedy is addressing the limited availability of specialized treatment for time-critical cardiovascular emergencies, with the long-term goal of enabling expert intervention regardless of patient location.
Job requirements
- 10+ years of regulatory affairs experience in medical devices, including direct leadership of at least one Class III device through FDA submission (IDE → PMA or De Novo)
- Hands-on experience authoring IDE and PMA/De Novo submissions, not solely in a managerial capacity
- Strong working knowledge of 21 CFR Parts 812, 814, and 820; ISO 13485; and ISO 14971
- Experience with FDA guidance for AI/ML-enabled devices and the Predetermined Change Control Plan (PCCP) framework
- Proven track record of leading FDA pre-submission (Q-Sub) meetings and managing ongoing regulatory correspondence
- Demonstrated ability to serve as the primary FDA-facing representative for an organization
- Exceptional written and verbal communication skills, with the ability to develop submission-quality narratives, present to executive leadership and boards, and effectively engage cross-functional technical stakeholders
- Bachelor’s degree required; advanced degree (MS, PhD, JD, MBA) or RAC certification preferred