Jobs / United States / Hinge Health INC
Senior Regulatory Affairs Program Manager
Hinge Health INC · 🇺🇸 San Francisco-HQ
Sponsorship verdict
Sponsorship possible
One solid signal, not two — worth applying, and worth asking about sponsorship early.
- Employer is on a government sponsor recordThe US Department of Labor certified 13 H-1B/E-3 labor condition applications for this employer between Oct 2025 and Jun 2026 (latest Jun 2026) — the step every H-1B hire needs first. USCIS also records 6 H-1B approvals in FY2023. Source: LCA disclosure data (US Department of Labor (OFLC)).
- The posting doesn’t mention sponsorshipSilence isn’t a refusal — ask the recruiter before investing much time.
- No salary bar for this routeH-1B has no fixed salary bar: the employer must pay at least the prevailing wage for the role and area. Cap-subject employers enter a lottery weighted by wage level. Source: https://www.federalregister.gov/documents/2025/12/29/2025-23853/weighted-selection-process-for-registrants-and-petitioners-seeking-to-file-cap-subject-h-1b, rules effective 2026-02-27.
- What Hinge Health INC paid sponsored hires in similar roles1 certified filing for “Product Manager, Member Journey” (Information Technology Project Managers) in CA: $150k–$150k, median $150k. Most were filed at wage level II (100%) — 2 lottery entries, ≈31% projected selection odds for cap-subject employers. Source: US Department of Labor LCA disclosure data (Oct 2025 – Jun 2026).
- Confirmed live todayWhen a source last listed this job as open.
US H-1B: cap-subject employers enter a lottery weighted by wage level — Level I gets 1 entry, Level IV gets 4 (DHS projected selection odds ≈15% at Level I to ≈61% at Level IV). Universities and non-profit research employers are cap-exempt. The $100,000 fee for new petitions from abroad is currently blocked by a court order (appeal pending).
A verdict summarises public evidence; it is not legal advice and never a guarantee — the employer and the immigration authority decide. Sign in to factor in where you can already work.
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Sponsor Radar — Hinge Health INC
The US Department of Labor certified 13 H-1B/E-3 labor condition applications for this employer between Oct 2025 and Jun 2026 (latest Jun 2026) — the step every H-1B hire needs first. USCIS also records 6 H-1B approvals in FY2023. Source: LCA disclosure data (US Department of Labor (OFLC)).
Past sponsorship or register membership never guarantees sponsorship for this vacancy or for you. Full Sponsor Radar for Hinge Health INC →
About the role
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. 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. 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 QUALIFICATIONS: - 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 i