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Hinge Health

Senior Regulatory Affairs Program Manager

Who can apply: US-based role. The employer has not said which states are eligible — confirm before applying.
Location as listed by the employer: “San Francisco-HQ”
Apply on Hinge Health's site ↗

Opens the employer's official application page.

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About this role

Hinge Health is hiring for a Senior Regulatory Affairs Program Manager role (full-time). See the official posting for full details.

Requirements

  • 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.
  • 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 Co…
  • 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.

Summarized from the employer's posting — check the full posting for every requirement.