# Senior Regulatory Affairs Program Manager at Hinge Health

- Company: Hinge Health
- What the company does: The #1 clinic for joint & muscle pain. Join today and take control of your pain with access to our personalized virtual physical therapy program. Backed by Bessemer and Insight.
- Company website: https://www.hingehealth.com/
- Type: Startups
- Level: Senior
- Location: San Francisco-HQ
- Work setup: Remote
- Pay: $168K to $225K base salary per year (USD)
- Posted: 2026-10-09
- Apply by: 2026-11-23
- Apply: https://jobs.ashbyhq.com/hinge-health/45e3a1d2-e640-4545-b9d2-c9b337fb228d?utm_source=1752vc&utm_medium=careers
- Page: https://www.1752.vc/careers/jobs/hinge-health-senior-regulatory-affairs-program-manager/

## About the role

Senior Regulatory Affairs Program Manager is the primary regulatory strategist and architect for our AI/ML Software as a Medical Device (SaMD) portfolio. While many companies view Regulatory Affairs as a purely administrative function, at Hinge Health we leverage this role as a technical discipline. Found on 1752vc Careers, the job board for startup and VC roles.

## What they're looking for

- Education: Bachelor’s degree in Biomedical Engineering, Software Engineering, Regulatory Science, or a related technical/scientific field
- Experience: A minimum of 4-6 + years of experience in Regulatory Affairs within the medical device industry, with a minimum of 3 years focused on Software as a Medical Device (SaMD) or Digital Health
- Submission Expertise: Proven track record of authoring and clearing US FDA Class II submissions (510(k) or De Novo). Experience interfacing directly with FDA reviewers during the review clock
- Technical Fluency: Ability to understand software architecture, cloud infrastructure, and AI/ML concepts sufficiently to describe them to regulators. Familiarity with IEC 62304 and FDA Guidance on Software Validation
- AI/ML Specifics: Direct experience with regulatory submissions involving Machine Learning, Deep Learning, or Computer Vision. Familiarity with Good Machine Learning Practice (GMLP) principles and Predetermined Change Control Plans (PCCP)
- International Experience: Experience with international registrations, particularly EU MDR (CE Marking) for software, or Health Canada requirements

Tags: RnD

Source: 1752vc Careers, https://www.1752.vc/careers/jobs/hinge-health-senior-regulatory-affairs-program-manager/