AI/ML SaMD Regulatory Program Lead
ALT.com
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.
#J-18808-LjbffrVacancy posted 4 days ago
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