Senior Regulatory Affairs Program Manager

The role

You will act as the primary regulatory strategist and architect for an AI/ML Software as a Medical Device portfolio. You will author and manage regulatory submissions and partner with Product, Clinical, and Engineering teams to navigate FDA frameworks.

What you will do

• Lead the planning, authorship, and submission of regulatory filings for AI/ML-enabled software.
• Develop and execute regulatory strategies for new product introductions and major software updates.
• Participate in Design Reviews and Change Control Boards to assess regulatory impact of software changes.
• Support the maintenance of the Quality Management System.
• Act as the Regulatory representative during internal and external audits.
• Review and approve labeling, marketing materials, and user manuals.
• Partner with Quality to monitor post-market performance of AI models.
• Lead the assessment of complaints for regulatory reporting requirements and manage recalls or field actions.
• Educate technical teams on regulatory principles.

Required qualifications

• Bachelor’s degree in Biomedical Engineering, Software Engineering, Regulatory Science, or a related technical/scientific field.
• Minimum of 4-6 + years of experience in Regulatory Affairs within the medical device industry.
• Minimum of 3 years focused on Software as a Medical Device (SaMD) or Digital Health.
• 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.
• Ability to understand software architecture, cloud infrastructure, and AI/ML concepts.
• Familiarity with IEC 62304 and FDA Guidance on Software Validation.

Nice to have

• 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.
• Experience working in an Agile/Scrum environment.

Benefits

• Comprehensive medical, dental, and vision coverage.
• Help with gender-affirming care.
• Tools for family and fertility planning.
• Travel reimbursements if healthcare isn’t available where you live.
• Traditional or Roth 401k retirement plan options with a 2% company match.
• Modern life stipends for learning and development.
• Discounted company stock through ESPP.

About the company

Hinge Health uses technology to scale and automate the delivery of healthcare for musculoskeletal (MSK) conditions. The company is headquartered in San Francisco with additional offices in Montreal and Bangalore.