Head of Regulatory Affairs

remedyrobotics; San Francisco (CA); Hybrid; USD 220,000 - 320,000; Full time

Benefits offered by this job

Equity

401k + company match

Health, dental, and vision insurance

20 days PTO per year

Commuter benefits - Bay Area

Job summary

Remedy Robotics seeks a Head of Regulatory Affairs to lead the regulatory strategy from IDE through PMA/De Novo and act as the primary FDA contact. You will shape AI/ML and autonomous device submissions and align US timelines with CE/MDR globally.

Collaborating with Clinical Ops, Quality, and Program Management, you’ll ensure submission readiness and regulatory compliance. 10+ years in medical devices required; SF-based with equity and benefits.

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 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

Responsibilities

• 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
• 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
• 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

Skills

FDA submissions

Regulatory leadership

21 CFR 812/814/820

PCCP framework

AI/ML regulatory

Education

Bachelor's degree

MS/PhD/JD/MBA RAC preferred

Job description

Remedy Robotics 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