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.
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.
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
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
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
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