Senior Regulatory Affairs Program Manager
About The Position
The Senior Regulatory Affairs Program Manager is the primary regulatory strategist and architect for Hinge Health’s AI/ML Software as a Medical Device (SaMD) portfolio. The role is a hands-on technical regulatory position focused on authoring and managing submissions for AI products, including 510(k), De Novo, and pre-submissions. It partners with Product, Clinical, and Engineering teams to interpret FDA requirements for AI/ML and navigate pathways such as Predetermined Change Control Plans (PCCP). The position also supports internal regulatory functions connected to the Quality Management System (QMS), helping maintain compliance while the company innovates. The role leads regulatory strategy for product introductions and major software updates; assesses regulatory impact from software and AI model changes; supports QMS procedures and audits; reviews labeling and promotional materials; and works with Quality on post-market monitoring, complaint reporting, recalls, and field actions. It also coaches technical teams on regulatory principles and submission documentation.
Requirements
- Bachelor’s degree in Biomedical Engineering, Software Engineering, Regulatory Science, or a related technical or scientific field.
- At least 4–6+ years of Regulatory Affairs experience in the medical device industry, including at least 3 years focused on SaMD or Digital Health.
- Proven track record authoring and obtaining clearance for US FDA Class II submissions (510(k) or De Novo).
- Experience interfacing directly with FDA reviewers during the review clock.
- 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.
Nice To Haves
- 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).
- Experience with international registrations, particularly EU MDR (CE Marking) for software or Health Canada requirements.
- Ability to review statistical analysis plans and clinical validation reports for regulatory expectations regarding substantial equivalence or safety and effectiveness.
- Experience in an Agile/Scrum environment and adapting regulatory submission timelines to iterative software release cycles.
Responsibilities
- Lead the planning, authorship, and submission of regulatory filings for AI/ML-enabled software, including 510(k), De Novo, and Q-Submissions.
- Develop and execute regulatory strategies for new product introductions and major software updates.
- Advise on FDA AI/ML policy, including validation and monitoring of adaptive algorithms and pathways such as PCCP.
- Participate in Design Reviews and Change Control Boards to assess the regulatory impact of software changes, including AI model and retraining-pipeline changes.
- Determine when software changes require a new 510(k) or a Letter to File.
- Support maintenance of the QMS by ensuring regulatory requirements are reflected in internal procedures.
- Represent Regulatory Affairs during internal and external FDA and ISO audits.
- Review and approve labeling, marketing materials, and user manuals for substantiated claims consistent with cleared indications for use.
- Partner with Quality to monitor post-market AI model performance and assess complaints for regulatory reporting requirements such as eMDRs.
- Manage necessary recalls or field actions.
- Educate technical teams on regulatory principles and how engineering documentation supports regulatory clearance.
Benefits
- Comprehensive medical, dental, and vision coverage.
- Support for employees and family members with gender-affirming care, family and fertility planning tools, and travel reimbursements when healthcare is unavailable where they live.
- Traditional or Roth 401(k) retirement plan options with a 2% company match.
- Learning and development stipend.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
