--- title: 'Staff Regulatory Affairs Engineer at Hinge Health' canonical: 'https://feeny.ai/job/staff-regulatory-affairs-engineer-hinge-health-san-francisco-f5rncf4z78q4' type: 'job' last_seen: '2026-09-24' --- # Staff Regulatory Affairs Engineer at Hinge Health - **Company:** [Hinge Health](https://feeny.ai/companies/hinge-health) - **Location:** San Francisco, CA - **Compensation:** $168k–$225k - **Employment:** full-time - **Work type:** hybrid - **Posted:** 2026-04-08 - **Last confirmed live:** 2026-09-24 - **Apply:** https://jobs.ashbyhq.com/hinge-health/45e3a1d2-e640-4545-b9d2-c9b337fb228d/application **Skills:** Regulatory Affairs, FDA 510(k) Submissions, De Novo Submissions, Software as Medical Device (SaMD), Cloud Infrastructure, AI/ML Concepts, IEC 62304, FDA Guidance on Software Validation, Design Controls, Change Control Boards (CCB), Quality Management System (QMS), 21 CFR 820, ISO 13485, Machine Learning Regulatory Submissions, Deep Learning Regulatory Submissions, Computer Vision Regulatory Submissions, Good Machine Learning Practice (GMLP), Predetermined Change Control Plans (PCCP), EU MDR (CE Marking), Health Canada Requirements > The Staff Regulatory Affairs Engineer serves as the primary regulatory strategist for AI/ML SaMD, leading the authorship and management of FDA submissions such as 510(k) and De Novo filings. This role involves developing regulatory strategies, managing design controls, supporting the Quality Management System, and e... ## Job description ## About The Role The Staff Regulatory Affairs Engineer 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—hence the "Engineer" title. 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 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. ## 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 athttp://www.hingehealth.com/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 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.](https://www.hingehealth.com/about/personnel-and-candidate-privacy-policy/) 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](http://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 [security@hingehealth.com](https://app.ashbyhq.com/admin/organizational-settings/theme#). ## About Hinge Health ## Company Overview - **One-liner**: Hinge Health delivers personalized virtual physical therapy and musculoskeletal (MSK) care by combining AI-powered motion tracking, an FDA-cleared wearable device, and a dedicated clinical care team. - **Entity Type**: Public (NYSE: HNGE) - **Headquarters**: San Francisco, California, United States - **Founded**: 2014 - **Founders**: Gabriel Mecklenburg (Co-founder & Executive Chairman / CTO) ## Core Business - **Primary Industry**: Digital Healthcare – Musculoskeletal (MSK) and pelvic health. - **Target Customers**: B2B – employers, health plans, and benefits brokers. Indirectly B2C through members. - **Mission**: To create a new healthcare system built around the individual – moving beyond traditional physical therapy to deliver accessible, scalable, evidence-based pain care. ## Products & Services - **Virtual Physical Therapy Program**: Personalized care plans with guided exercise sessions using 3D motion tracking for real-time feedback and precision movement analysis. Includes access to a physical therapist, health coach, and orthopedic specialist. - **Enso® Wearable Device**: FDA-cleared device that uses patented waveforms for drug-free pain relief; exclusive to Hinge Health. - **AI Care Assistant**: An AI agent that helps members stay on track with their care plans. - **Pelvic Floor Therapy**: Virtual care for pelvic health, integrated with MSK services. - **Enterprise Implementation**: Seamless eligibility, billing, and reporting through partnerships with 5 out of 5 national health plans and 3 out of 3 PBMs. Value-based pricing and frictionless contracting. ## Market Standing - **Valuation / Market Cap**: Not publicly available (post-IPO; specific market cap not disclosed in provided sources). - **Key Metric**: Annual Revenue of **$587.9M** (2025) – [linkedin.com](https://www.linkedin.com/company/hinge-health). Total funding raised: **$1.46B**. - **Notable Investors / Partners**: Tiger Global Management, Coatue, Alkeon Capital, Whale Rock Capital Management. - **Growth Signals**: IPO in May 2025; headcount of 1,254 (+1.2% YoY); 75 active job postings (+31.6% year over year); expanded into pelvic floor therapy; operates in 11 countries. ## Competitive Advantages - **Clinically validated ROI** – independently validated 2.4x hard dollar return on investment for employers. - **AI-first care model** – uses 3D motion tracking, autonomous AI agents for reasoning and feedback, and regulatory-grade systems. - **Exclusive FDA-cleared device** (Enso®) that differentiates from traditional PT offerings. - **Deep integration** with major national health plans and PBMs, creating high switching costs. - **Business model aligned with outcomes** – revenue is tied to healing people, not billing procedures, enabling investment in direct care automation. ## Strategic Focus - Scale and automate healthcare delivery by building AI agents that perceive movement, reason biomechanics, and adapt clinical guidance in real time. - Expand into adjacent conditions (pelvic health) and deepen partnership integrations. - Continue engineering a culture where “designers code” and “engineers build interactive prototypes,” deploying agent-first workflows across hundreds of engineers. ## Why Work Here - **Culture**: Emphasis on autonomy, mastery, and purpose. The R&D blog describes an environment where engineers review reasoning logs instead of diffs and where AI agents ship PRs without human line edits. - **Work Model**: Hybrid/office presence – HQ in San Francisco with offices in India, Canada, UK, and Colombia. Specific remote policy not detailed in sources. - **Impact**: Opportunity to work on regulatory-grade AI that directly improves clinical outcomes for millions of people. - **Reviews**: Employer rating of 3.8/5 on LinkedIn; strong scores for work-life balance (3.7) and compensation (3.7). - **Notable Perks**: Not explicitly listed, but the culture of “impact at scale” and investment in R&D suggests strong engineering support. ## Sources 1. [hingehealth.com](https://www.hingehealth.com/) 2. [hingehealth.com/about](https://www.hingehealth.com/about/) 3. [rnd.hingehealth.com](https://rnd.hingehealth.com/) 4. [linkedin.com/company/hinge-health](https://www.linkedin.com/company/hinge-health) 5. [jobs.ashbyhq.com/hinge-health](https://jobs.ashbyhq.com/hinge-health) ## Other roles at Hinge Health - [Associate Health Coach, Flex](https://feeny.ai/job/associate-health-coach-flex-hinge-health-united-states-g424e33w5gpz) — United States - [Senior Software Engineer-Backend](https://feeny.ai/job/senior-software-engineer-backend-hinge-health-bengaluru-ara6p8k1wjc9) — Bengaluru, India - [Sr. Product Manager, R&D Enablement](https://feeny.ai/job/sr-product-manager-r-d-enablement-hinge-health-san-francisco-q4mn8yq6ty3p) — San Francisco, CA - [Recruiting Coordinator - Contract](https://feeny.ai/job/recruiting-coordinator-contract-hinge-health-san-francisco-s93bpxz0v59q) — San Francisco, CA - [Associate General Counsel, Product](https://feeny.ai/job/associate-general-counsel-product-hinge-health-san-francisco-tych722cgwqk) — San Francisco, CA - [Registered Dietitian (Flex)](https://feeny.ai/job/registered-dietitian-flex-hinge-health-united-states-nq9ddwjkjwy0) — United States - [Data Engineer II](https://feeny.ai/job/data-engineer-ii-hinge-health-bengaluru-xv0m5r87bd2f) — Bengaluru, India - [Pelvic Health Physical Therapist, Flex](https://feeny.ai/job/pelvic-health-physical-therapist-flex-hinge-health-united-states-0pxte6fjpe0p) — United States - [Enrollment Marketing Associate](https://feeny.ai/job/enrollment-marketing-associate-hinge-health-san-francisco-sp7b3kfvh4bv) — San Francisco, CA - [Physical Therapist, Flex](https://feeny.ai/job/physical-therapist-flex-hinge-health-united-states-cyq8kpm0tkeh) — United States