Regulatory Affairs Lead (SaMD)
Rad AI · Berkeley, CA · Hybrid
Salary range sourced from Levels.fyi, Pave, and Synaxia placement history · Company intel: Crunchbase · StackShare · BuiltWith
About the role
Own Rad AI's regulatory strategy across FDA, MDR, and international markets for AI-based SaMD. We're looking for someone curious, pragmatic, and eager to work across the stack with a small senior team. You'll own end-to-end delivery of major features, influence architecture, and mentor engineers.
What you'll do
- Ship customer-facing features on a weekly cadence.
- Partner with design and product on scoping and trade-offs.
- Drive technical quality through review, testing, and docs.
- Mentor one or two engineers on your team.
Requirements
- 6+ years regulatory in medical devices or SaMD
- Deep 510(k) experience
- QMS / ISO 13485
FDA 510(k)SaMDQMSISO 13485
Hiring process
- Application review · 2 days
- Recruiter screen · 30 min
- Technical interview · 90 min
- Onsite loop · 3–4 hours
- Offer
Company
R
Rad AI
Regulatory · 18 applicants
Mission-driven team building for a global audience. Remote-first, async-leaning, ships twice a week.
Why you'd fit
- Your top skills match 4/5 requirements
- Salary range matches your preferences
- Location match: Berkeley, CA · Hybrid
- Add 2 more healthcare projects to your profile to lift your match score