New · posted Oct 15
Hinge Health · Medical Devices
Senior Regulatory Affairs Program Manager
- San Francisco, CA
- Hybrid
- Full-time
- Manager
Open until filled
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.
In this role, you will be responsible for the hands-on authorship and management of regulatory submissions (510(k), De Novo, Pre-Subs) for our cutting-edge AI products. You will partner closely with Product, Clinical, and Engineering teams to interpret the evolving FDA framework for AI/ML, helping us navigate complex pathways like Predetermined Change Control Plans (PCCP). You will also own the internal regulatory functions that support our Quality Management System, ensuring our rapid innovation remains compliant.
What You’ll Accomplish
Submission Leadership (AI/ML SaMD): Lead the planning, authorship, and submission of regulatory filings (510(k), De Novo, Q-Submissions) for AI/ML-enabled software. You will be the primary author, not just a reviewer, translating complex technical and clinical data into compelling regulatory narratives.
Regulatory Strategy & AI Policy: Develop and execute regulatory strategies for new product introductions and major software updates. You will serve as the internal authority on the FDA’s evolving AI/ML Action Plan, guiding the business on how to validate and monitor adaptive algorithms.
Design Control & Change Impact: Participate in Design Reviews and Change Control Boards (CCB) to assess the regulatory impact of software changes. You will determine when a new 510(k) or "Letter to File" is required, specifically evaluating changes to AI models and retraining pipelines.
QMS & Internal Compliance: Support the maintenance of the Quality Management System (QMS) by ensuring regulatory requirements (21 CFR 820, ISO 13485) are reflected in internal procedures. You will act as the Regulatory representative during internal and external audits (FDA, ISO).
Promotional Review: Review and approve labeling, marketing materials, and user manuals to ensure claims are substantiated and consistent with cleared indications for use.
Post-Market Surveillance & Vigilance: Partner with Quality to monitor post-market performance of AI models. You will lead the assessment of complaints for regulatory reporting requirements (e.g., eMDRs) and manage any necessary recalls or field actions.
Cross-Functional Coaching: Educate technical teams on regulatory principles, demystifying the submission process and helping engineers understand how their documentation directly supports regulatory clearance.
What you need
Basic Qualifications
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.
Preferred Qualificationsnice to have
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.
Data Analysis: Ability to review statistical analysis plans and clinical validation reports to ensure they meet regulatory expectations for substantial equivalence or safety/effectiveness.
Agile Integration: Experience working in an Agile/Scrum environment and adapting regulatory submission timelines to iterative software release cycles.
Pay and benefits
$168,000 – $225,000 a year
Employer providedMedical, dental, and vision coverage
Gender-affirming care, family and fertility planning support
Travel reimbursement for unavailable healthcare
2%
401k (traditional or Roth) with 2% company match
Learning and development stipend
Where you'll work
San Francisco, CAHybridOpen in Maps (opens in a new tab)
More jobs in San Francisco, CAFrom the posting
About Hinge Health
Hinge Health leverages software, including AI, to largely automate care for joint and muscle health, delivering an outstanding member experience, improved member outcomes, and cost reductions for its clients. The company has designed its platform to address a broad spectrum of MSK care—from acute injury, to chronic pain, to post-surgical rehabilitation—and the platform can help to ease members’ pain, improve their function, and reduce their need for surgeries, all while driving health equity by allowing members to engage in their exercise therapy sessions from anywhere. The company is headquartered in San Francisco, California.
Learn more at http://www.hingehealth.com
What You'll Love About Us
Inclusive healthcare and benefits: On top of comprehensive medical, dental, and vision coverage, we offer employees and their family members help with gender-affirming care, tools for family and fertility planning, and travel reimbursements if healthcare isn’t available where you live.
Planning for the future: Start saving for the future with our traditional or Roth 401k retirement plan options which include a 2% company match.
Modern life stipends: Manage your own learning and development
Culture and Engagement
Beware of Phishing Attempts: We've noticed an increase in phishing where fraudsters impersonate employees and send fake job offers to steal sensitive information. We'll never ask for financial details during the hiring process and only use "@hingehealth.com" emails. If you receive a suspicious offer, stop communication and report it to the US FBI Internet Crime Complaint Center. To verify an email from our recruiting team, forward it to [email protected].
Equal opportunity, accessibility and legal noticesHinge Health's statements, word for word
Hinge Health is an equal opportunity employer and prohibits discrimination and harassment of any kind. We make employment decisions without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, age, veteran status, disability status, pregnancy, or any other basis protected by federal, state or local law. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. We provide reasonable accommodations for candidates with disabilities. If you feel you need assistance or an accommodation due to a disability, let us know by reaching out to your recruiter. By submitting your application you are acknowledging we are using your personal data as outlined in the personnel and candidate privacy policy.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 21% above the US median for Regulatory Affairs roles at this level.
This roleEmployer provided
Manager roles in California14 roles publishing pay
Manager roles in the US47 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $168,000 | — | $225,000 |
| California (middle half) | $159,000 | $171,000 | $179,500 |
| All US (middle half) | $146,750 | $162,500 | $177,750 |
This role: Hinge Health's own published range. Comparisons: the base pay employers published on open Regulatory Affairs roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Affairs
The general path across 290 open Regulatory Affairs roles on Regulatory Jobs, with the titles they carry most. Not Hinge Health's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 17 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Regulatory submissions10
- Data and digital systems10
- Collaboration and leadership5
- Documentation and SOPs4
- Quality systems and risk4
- Validation and qualification3
- GMP and compliance1
- Investigations and CAPA1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices
- European UnionEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- IECIEC 62304(official source, opens in a new tab)Software life cycle processes for medical device software
- FDAFDA 510(k)(official source, opens in a new tab)Premarket notification for medical devices
- FDAFDA De Novo(official source, opens in a new tab)Classification requests for novel low- to moderate-risk devices
Company hiring pulse
Hinge Health on Regulatory Jobs
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Senior Regulatory Affairs Program Manager at Hinge Health
Open until filled. $168K–$225K a year, employer provided.