Head of Regulatory Affairs
Remedy Robotics https://www.remedyrobotics.com/ 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. Headquartered in San Francisco, Remedy is backed by DCVC, Blackbird, and Tony Fadell's Build Collective, among others.
We are looking to hire a Head of Regulatory Affairs for our Clinical/Regulations Team.
What You’ll Do:
Regulatory strategy & FDA leadership
- Own the end-to-end regulatory roadmap from IDE through pivotal trial to PMA or De Novo authorization
- Serve as primary FDA contact (Q-Subs, pre-sub meetings, deficiency responses, panel prep)
- Define regulatory strategy for AI/ML and autonomous features, including PCCP where applicable
- Set and sequence OUS strategy (e.g., CE Mark/MDR and other markets) alongside US timelines
Submissions & regulatory documentation
- Author and lead IDE submission development across engineering, clinical, and quality teams
- Own regulatory content across the Design History File and ensure company-wide submission readiness
- Lead preparation and response for FDA inspections
- Write and manage Q-Sub (pre-submission) packages
Cross-functional execution & alignment
- Partner with Clinical Ops to align protocol execution with FDA-facing submission narrative
- Coordinate with Program Management on regulatory timelines and milestones
- Partner with Quality on QMS, ISO 13485/14971, IEC 62304, and design controls
- Represent regulatory function in executive and board communications
Minimum Qua...