Senior Regulatory Affairs Program Manager

Alt; San Francisco (CA); Hybrid; USD 180.000 - 240.000; Vollzeit

Benefits dieser Stelle

Hybrid work model

Dog-friendly office

Zusammenfassung

Hinge Health is seeking a Senior Regulatory Affairs Program Manager to lead regulatory strategy for our AI/ML SaMD portfolio. You will author submissions and collaborate with Product, Clinical, and Engineering teams to interpret evolving FDA guidance for AI/ML and ensure compliant rapid innovation.

You will own internal regulatory functions supporting the QMS, post-market surveillance, and audits, while guiding engineers on documentation for regulatory clearance.

Qualifikationen

• Bachelor’s degree in Biomedical Engineering, Software Engineering, Regulatory Science, or a related technical/scientific field.
• 4–6+ years of Regulatory Affairs experience in the medical device industry, with at least 3 years on SaMD or Digital Health.
• Proven ability to author and clear US FDA Class II submissions (510(k) or De Novo).
• Knowledge of IEC 62304 and FDA Software Validation guidance.

Aufgaben

• Lead submissions (510(k), De Novo, Q-Submissions) for AI/ML-enabled SaMD, authoring regulatory narratives.
• Develop regulatory strategies for new products and major software updates, including PCCP planning.
• Assess regulatory impact of software changes during design reviews and change control.
• Support QMS maintenance to reflect 21 CFR 820 and ISO 13485 in internal procedures.
• Review labeling and marketing materials to ensure alignment with cleared indications.
• Lead post-market surveillance and regulatory reporting obligations (eMDRs, recalls) with Quality.
• Educate engineering and product teams on regulatory requirements and submission processes.

Jobbeschreibung

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 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.

Hinge Health Hybrid Model

We believe that remote work and in-person work have their own advantages and disadvantages, and we want to be able to leverage the best of both worlds. Employees in hybrid roles are required to be in the office 3 days per week, for the full 8 hours of a typical business day. The San Francisco office has a dog-friendly workplace program.

About Hinge Health

At Hinge Health, we’re using technology to scale and automate the delivery of healthcare, starting with musculoskeletal (MSK) conditions, which affect over 1.7 billion people worldwide. Our AI-powered, human-centered care model spans MSK, pelvic health, gastrointestinal (GI) and migraine care. With over 60 partnerships with health plans, PBMs and other ecosystem partners, Hinge Health is available to over 25 million people across more than 2,900 employers. The company is headquartered in San Francisco with additional offices in Montreal and Bangalore. Learn more at 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.

• Grow with us: Grow with us through discounted company stock through our ESPP with easy payroll deductions.

Culture & 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.