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Head of Regulatory
Head of RegulatoryCatalyst MedTech Search • San Francisco, CA, United States
Head of Regulatory

Head of Regulatory

Catalyst MedTech Search • San Francisco, CA, United States
2 days ago
Job type
  • Full-time
Job description

Overview

Head of Regulatory & Quality

Location : San Francisco, CA

Reports to : CEO

Comp : 200-300k, Equity

About the Role

We’re building smarter surgical robotics using software and AI to improve outcomes and efficiency. We move fast and rely on first-principles thinking to ensure safety. You’ll lead regulatory efforts, balancing speed with rigor, and helping engineers own safety.

What You’ll Do

  • Lead FDA strategy and submissions (510(k) / De Novo) and enable frequent software releases.
  • Develop global regulatory strategy, including CE Mark under MDR and other international launches.
  • Translate regulations into actionable product requirements and partner with product, software, and clinical teams.
  • Automate regulatory processes and evidence collection using modern tools and AI.
  • Lead risk management activities, including hazard analyses, software risk, and cybersecurity.
  • Foster a safety-first culture and be hands-on in drafting, reviewing, and submitting regulatory documentation.

What You Bring

  • Strong systems engineering mindset, able to decompose complex hardware / software systems.
  • Experience with regulated software products and FDA / CE submissions.
  • Proven ability to build or evolve QMS that balances compliance with speed.
  • Track record of automating regulatory workflows and evidence capture.
  • Excellent communication and ability to influence teams and regulators.
  • Collaborative, curious, and intellectually honest—comfortable in a fast-moving environment.

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    Head Of Regulatory • San Francisco, CA, United States