Staff Regulatory Affairs Engineer
Hinge Health · San Francisco-HQ · US
Posted 60+ days ago
Regulatory Affairs
Hybrid
Not yet analysed
Demand80
Career growth85
Healthcare fit65
Remote potential70
5-year outlook
Salaries for senior regulatory affairs roles in digital health are competitive and likely to increase with AI/ML expertise. Expect six-figure compensation with experience, though exact figures vary by location and company.
Clinical license
Not required
Applicant reach
narrow
Seniority
senior
Employment type
full-time
Date found
2026-08-26
Intelligence details
Why this is worth applying to
For clinicians with regulatory affairs experience or a strong interest in health tech regulation, this role offers a unique opportunity to leverage clinical knowledge in a non-clinical, high-impact position. However, without the required 4-6+ years of regulatory experience, it is not a realistic entry point.
Who should apply
Clinicians (doctors, nurses, pharmacists, allied health) who have transitioned into regulatory affairs, or those with engineering backgrounds and clinical domain expertise. Ideal for those with prior 510(k) or De Novo submission experience and familiarity with AI/ML in healthcare.
CV angle
Highlight clinical experience as domain expertise for understanding medical device use cases, patient safety, and clinical data interpretation. Emphasize any experience with quality systems, compliance, documentation, or cross-functional collaboration.
Skills to highlight
- Regulatory submissions
- 510(k) experience
- AI/ML knowledge
- QMS
- ISO 13485
- FDA regulations
- Cross-functional collaboration
- Technical writing
Role summary
A senior regulatory affairs role responsible for leading FDA submissions for AI/ML software as a medical device, developing regulatory strategy, and ensuring compliance with QMS and evolving FDA guidance.
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