Hinge Health
Hinge Health is hiring a Staff Regulatory Affairs Engineer in San Francisco, California, to serve as the lead regulatory strategist behind our AI/ML Software as a Medical Device (SaMD) portfolio. This is a full-time, on-site position for a builder who treats regulatory affairs as an engineering discipline, not paperwork.
About the Role
At Hinge Health, regulatory affairs is a technical craft — which is exactly why this role carries the "Engineer" title. As the Staff Regulatory Affairs Engineer, you will own the regulatory blueprint for our artificial intelligence and machine learning medical software, shaping how innovative SaMD products reach patients safely and compliantly. You will pair deep regulatory knowledge with hands-on technical fluency, working shoulder-to-shoulder with engineering and product teams in San Francisco.
Key Responsibilities
- Define and drive the regulatory strategy for Hinge Health's AI/ML SaMD product line.
- Author and assemble regulatory submissions and supporting technical documentation directly, rather than delegating the detail.
- Act as the architect translating product and engineering decisions into compliant regulatory pathways.
- Partner cross-functionally with software, data science, quality, and clinical teams to embed compliance early in development.
- Interpret evolving guidance for AI- and ML-enabled medical devices and advise stakeholders on its impact.
Qualifications
- Substantial experience in regulatory affairs for medical devices, ideally Software as a Medical Device (SaMD).
- Working familiarity with AI/ML-driven products and the technical concepts behind them.
- Proven ability to author regulatory submissions and technical files with a hands-on, detail-oriented approach.
- Strong collaboration skills for partnering with engineering and product organizations.
- Comfort operating at a staff level — setting strategy while remaining close to the technical work.
About Hinge Health
Hinge Health builds technology-driven solutions at the intersection of healthcare and software. Our teams approach regulatory affairs as a technical discipline, giving engineers and strategists alike a meaningful voice in how compliant, patient-centered medical software is designed and delivered.
How to Apply
Ready to bring an engineer's mindset to regulatory strategy? Apply for the Staff Regulatory Affairs Engineer role at Hinge Health in San Francisco, California, through our official job listing.
To apply for this job please visit www.adzuna.com.
Working in San Francisco
San Francisco, officially the City and County of San Francisco, is the fourth-most populous city in California and the 17th-most populous in the United States, with a population of 826,079 in 2025. Among U.S. cities with a population of 200,000 or more, San Francisco is ranked first by per capita income, second by population density, and sixth by aggregate income as of 2024. Some 4.6 million residents live in the city's metropolitan statistical area, which is the 13th-largest in the United States. Around 9.2 million live in the San Jose–San Francisco–Oakland combined statistical area, the fift
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