AI/ML SaMD Regulatory Program Lead

Alt; San Francisco (CA); Hybrid; USD 180,000 - 240,000; Full time

Benefits offered by this job

Hybrid work model

Dog-friendly office

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Job description

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.