Head of Regulatory Affairs

Remedy Robotics

Head of Regulatory Affairs leading FDA submissions for an autonomous surgical device. Collaborating cross-functionally to ensure compliance and marketing authorization in the medical device sector.

Posted 5/19/2026full-timeSan Francisco • California • 🇺🇸 United StatesLeadWebsite

About the role

Key responsibilities & impact

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
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

Requirements

What you’ll need

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.

Benefits

Comp & perks

Health insurance
Flexible work arrangements
Professional development opportunities

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory roadmapIDE submissionPMA submissionDe Novo authorizationPredetermined Change Control Plandesign history fileQ-Sub packagesFDA inspection preparationclinical submissionsquality management system

Soft Skills

communicationcollaborationleadershipproblem-solvingorganizational skillsnegotiationattention to detailstrategic thinkingcross-functional teamworkpresentation skills

Certifications

Bachelor's degreeadvanced degree (MS, PhD, JD, MBA, RAC)