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.