Remedy Robotics
Head of Regulatory Affairs
San Francisco (hybrid) · Mid
Sponsorship not specifiedDetected 64 days ago
Machine LearningComputer VisionRoboticsFDA RegulatoryMedical DevicesLeadershipCommunicationRegulatory Affairs
About the role
- 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
Responsibilities
- Own the end-to-end regulatory roadmap from IDE through pivotal trial to PMA or De Novo authorization
- 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
- Partner with Clinical Ops to align protocol execution with FDA-facing submission narrative
- Partner with Quality on QMS, ISO 13485/14971, IEC 62304, and design controls
- Headquartered in San Francisco, Remedy is backed by DCVC, Blackbird, and Tony Fadell's Build Collective, among others.
Requirements
- Strong working knowledge of 21 CFR Parts 812, 814, and 820
- 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
Nice to have
- Experience with FDA Breakthrough Device Designation programs
- Experience designing real-world evidence strategies and post-market surveillance frameworks
- Bachelor's degree required
- advanced degree (MS, PhD, JD, MBA) or RAC certification preferred
Benefits
- Remedy Robotics https://www.remedyrobotics.com/ is a medical technology company developing robotic systems for endovascular intervention.
Company info
- We are looking to hire a Head of Regulatory Affairs for our Clinical/Regulations Team.
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This listing is sourced directly from Remedy Robotics's careers page and normalized into a canonical job model.