Head of Regulatory Affairs

ABOUT REMEDY ROBOTICS Cardiovascular disease is the #1 cause of morbidity and mortality in the world. Much of this could be prevented with better access to specialist care. Take stroke as an example: any delay in treatment can lead to permanent disability or death. However, due to a lack of specialist surgeons, the most effective intervention can only be performed in 2% of US hospitals. For patients who present to one of the 98% of hospitals that do not offer the surgery, treatment is either significantly delayed or not offered at all because timely transfer is not feasible. Our mission is to bring state-of-the-art vascular intervention to anyone, anytime, regardless of their location. Our team of medical clinicians, roboticists, and machine learning experts are working to bridge this gap by building the world’s first remotely-operated, semi-autonomous endovascular surgical robot. We’ve already done what nobody else could—using our system, doctors from around the world were able to remotely perform this procedure from as far as 8000 miles away. We now need your help to bring this technology out of the laboratory and into hospitals everywhere. THE ROLE You'll own the regulatory strategy and FDA-facing voice for Remedy as we move through IDE submission, our pivotal trial, and market authorization. This is a strategic + hands-on role: you'll set the regulatory roadmap and personally author the submission narratives — we're too small for a Head of Reg who only delegates. You'll work directly with the CEO, engineering, clinical operations, and quality to land an autonomous Class III surgical device with the FDA. YOU WILL Strategy and FDA interface - Own the regulatory roadmap from IDE through pivotal trial to PMA or De Novo authorization - Serve as the primary FDA point of contact — pre-submission meetings, IDE submission, deficiency responses, panel preparation - Define the regulatory strategy for our autonomous and AI/ML-enabled features, including a Predetermined Change Control Plan (PCCP) where appropriate - Set OUS regulatory strategy (CE Mark / MDR, plus initial thinking on other markets) and sequence it against US timelines Submissions and documentation - Author the IDE submission and lead the cross-functional authoring effort with engineering, clinical, and quality - Own the regulatory portions of the design history file and ensure submission readiness across the company - Write and own pre-submission Q-Sub packages - Lead FDA inspection preparation and response Cross-functional partnership - Partner with the Head of Clinical Operations on the clinical sections of submissions — ClinOps owns trial execution and protocol authoring; you own how it lands at FDA - Partner with Faiyaz (VP Program Management) on submission timelines and milestones - Partner with the Quality Lead on QMS, IEC 62304, and the design control narrative - Represent regulatory in executive and board updates YOU HAVE - 10+ years in regulatory affairs at medical device companies, with at least one Class III device personally led through FDA submission (IDE → PMA or De Novo) - Direct experience authoring IDE and PMA/De Novo submissions — not just managing the people who author them - 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 - Comfort being the FDA-facing voice for the company - Excellent written and verbal communication — you can write a submission narrative that holds up, brief a board, and push back on an engineer in the same week - Bachelor's degree required; advanced degree (MS, PhD, JD, MBA, RAC) preferred NICE TO HAVES - Surgical robotics, autonomous medical device, or other novel Class III device experience - Breakthrough Device Designation experience - Software-as-a-Medical-Device (SaMD) and AI/ML-specific submission experience - OUS regulatory strategy: CE Mark / EU MDR, PMDA (Japan), NMPA (China), Health Canada - Real-world evidence and post-market surveillance design - Prior startup experience where you built the regulatory function from scratch