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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. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- 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 Control Plans (PCCP)
- International Experience: Experience with international registrations, particularly EU MDR (CE Marking) for software, or Health Canada requirements
More about this 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.
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...
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