Regulatory Affairs Lead (SaMD)
Regulatory · Berkeley, CA · Hybrid · 18 applicants
Status
Views
2,184
Applicants
18
In pipeline
12
Days open
12
Description
Own Rad AI's regulatory strategy across FDA, MDR, and international markets for AI-based SaMD.
Requirements
- 6+ years regulatory in medical devices or SaMD
- Deep 510(k) experience
- QMS / ISO 13485
FDA 510(k)SaMDQMSISO 13485
Sharing & distribution
Careers page Synaxia matches LinkedIn Indeed
Details
- Status
- Open
- Posted
- 2026-04-04
- Type
- Full-time
- Salary
- $195K – $240K
- Team
- Regulatory
- Source
- AAshby Jobs API
Salary band sourced from Levels.fyi · Pave · Synaxia placements · Company intel: Crunchbase · StackShare · BuiltWith
Hiring team
- Priya Shah · Hiring manager
- Diego Alvarez · Interviewer
- Jordan Lee · Recruiter