---
title: 'Head of Regulatory Affairs at Remedy Robotics'
canonical: 'https://feeny.ai/job/head-of-regulatory-affairs-remedy-robotics-san-francisco-s6dwhdefxyf2'
type: 'job'
last_seen: '2026-09-15'
---

# Head of Regulatory Affairs at Remedy Robotics

- **Company:** Remedy Robotics
- **Location:** San Francisco, CA
- **Employment:** full-time
- **Work type:** hybrid
- **Posted:** 2026-05-19
- **Last confirmed live:** 2026-09-15
- **Apply:** https://jobs.ashbyhq.com/remedyrobotics/d93cb817-4a4a-4056-80fe-4c350ee566df

## Job description

[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 Qualifications:

- 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

Preferred Qualifications:

- Experience in surgical robotics, autonomous medical devices, or other novel Class III medical technologies
- Experience with FDA Breakthrough Device Designation programs
- Experience with Software as a Medical Device (SaMD) and AI/ML-enabled regulatory submissions
- Experience developing international regulatory strategies, including CE Mark / EU MDR, PMDA (Japan), NMPA (China), and Health Canada
- Experience designing real-world evidence strategies and post-market surveillance frameworks
- Prior experience in a startup environment, ideally with responsibility for building or scaling the regulatory function from the ground up

Benefits:

- Competitive salary, including equity
- 401k + company match
- Health, dental, and vision insurance
- 20 days PTO per year
- Commuter benefits within the Bay Area
- Well stocked snacks and Friday team lunches

## About Remedy Robotics

## Company Overview
- **One-liner**: Remedy Robotics builds the world’s first endovascular robot capable of performing entire procedures with onsite, remote, or autonomous control, aiming to make life-saving stroke and cardiovascular care accessible everywhere.
- **Entity Type**: Private (venture-backed; last round: $35M Venture Round in October 2025)
- **Headquarters**: San Francisco, California, United States
- **Founded**: 2021
- **Founders**: David Bell (CEO & Co-founder) and Jake Sganga (CTO & Co-founder)

## Core Business
- **Primary Industry**: Medical robotics / endovascular intervention (neurovascular and cardiovascular)
- **Target Customers**: Hospitals, health systems, and clinicians (B2B / Healthcare Enterprise)
- **Mission Statement**: “Deliver perfect, immediate endovascular intervention to every patient wherever they are in the world.”

## Products & Services
- **N1 Robotic System** (implied name): A Class III surgical robot that performs endovascular procedures (e.g., stroke thrombectomy, aneurysm coiling) with full robotic control, remote operation, and autonomous navigation capabilities. Integrates robotics, machine learning, and advanced computer vision. Type: Medical Device + Software.

## Market Standing
- **Valuation/Market Cap**: Not disclosed
- **Key Metric**: Total funding of $35M (Venture Round closed October 2025) [remedyrobotics.com](https://www.remedyrobotics.com/)
- **Notable Investors/Partners**: DCVC, Blackbird, Tony Fadell’s Build Collective; Strategic partners: Australian Stroke Alliance, SVIN Mission Thrombectomy (exclusive robotics partner) [remedyrobotics.com](https://www.remedyrobotics.com/news)
- **Growth Signals**: 
  - Completed world’s first fully remote neurointerventional procedures in humans (October 2025) [remedyrobotics.com](https://www.remedyrobotics.com/news)
  - First-in-human clinical procedures successfully performed; results published in American Journal of Neuroradiology (April 2025) [remedyrobotics.com](https://www.remedyrobotics.com/news)
  - Preparing for pivotal clinical trials (2026); 18 employees (+5.6% YoY); LinkedIn followers growing 113.8% yearly [linkedin.com](https://www.linkedin.com/company/remedyrobotics)

## Competitive Advantages
- **First-mover & clinical proof**: Only company to have performed completely robotic and fully remote neurointerventional procedures from start to finish in humans, plus autonomous endovascular navigation in models.
- **Full-stack robotics + AI**: Integrates hardware (catheters, robot arms), perception/planning autonomy, and teleoperation — a rare combination.
- **Mission-driven regulatory path**: Targeting Class III surgical device market authorization with a clear regulatory strategy (IDE submission, pivotal trial).

## Strategic Focus
- **Near-term**: Complete pivotal clinical trials and obtain FDA market authorization for the N1 system.
- **Growth**: Expand partnerships (e.g., Australian Stroke Alliance, SVIN Mission Thrombectomy) to accelerate deployment in the US and globally.
- **Product**: Continue advancing autonomous capabilities and remote operation for time-critical stroke and cardiovascular emergencies.

## Why Work Here
- **Culture**: Mission-driven, “stimulating, mission-driven and fun” workplace with deep medical and technical expertise [remedyrobotics.com](https://www.remedyrobotics.com/).
- **Work Model**: Hybrid (some roles in San Francisco office; a few roles fully remote) [builtin.com](https://builtin.com/company/remedy-robotics).
- **Engineering Culture**: Small multi-disciplinary team (18 people) with broad ownership; engineers work across autonomy, ML, hardware, and clinical integration. High-impact work on life-saving technology.
- **Notable Perks**: Not explicitly listed, but emphasis on career development, employee experience, and “a workplace where our team genuinely wants to show up” [remedyrobotics.com](https://www.remedyrobotics.com/).

## Sources
1. [remedyrobotics.com](https://www.remedyrobotics.com/) – Company overview, mission, product, history, jobs
2. [remedyrobotics.com/news](https://www.remedyrobotics.com/news) – Milestones, partnerships, clinical results
3. [linkedin.com](https://www.linkedin.com/company/remedyrobotics) – Employee count, growth, locations, funding
4. [cbinsights.com](https://www.cbinsights.com/company/remedy-robotics) – Funding details, patents, partnerships
5. [builtin.com](https://builtin.com/company/remedy-robotics) – Job listings, location details, company description

## Other roles at Remedy Robotics

- [R&D Technician](https://feeny.ai/job/r-d-technician-remedy-robotics-san-francisco-4bpyh5j66c2n) — San Francisco, CA
- [Senior Mechanical Engineer](https://feeny.ai/job/senior-mechanical-engineer-remedy-robotics-san-francisco-4rspnsxs4qdx) — San Francisco, CA
- [Dev Ops Engineer](https://feeny.ai/job/dev-ops-engineer-remedy-robotics-san-francisco-tg7sck4cb21z) — San Francisco, CA
- [Software Engineer](https://feeny.ai/job/software-engineer-remedy-robotics-san-francisco-tp0df4agjb4w) — San Francisco, CA
- [Autonomy Engineer](https://feeny.ai/job/autonomy-engineer-remedy-robotics-san-francisco-d7ffkvrasxw9) — San Francisco, CA
- [Senior Electrical Engineer](https://feeny.ai/job/senior-electrical-engineer-remedy-robotics-san-francisco-5dngpgn7xb6n) — San Francisco, CA
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