Director of AI Medical Devices
Company: VirtualVocations
Location: Vista
Posted on: May 24, 2025
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Job Description:
A company is looking for a Director, AI Medical Device Programs
to lead the development and regulatory execution of AI-powered
medical devices.
Key Responsibilities
Own the lifecycle of AI medical devices from R&D through
post-market surveillance
Lead regulatory strategy for AI/ML products to ensure compliance
with global standards
Drive post-market monitoring programs, including performance
tracking and continuous improvement cycles
Required Qualifications
5+ years of experience in SaMD and AI/ML product development, with
3+ years in a regulated healthcare setting
Proven track record leading cross-functional teams through design,
development, and regulatory clearance of AI-based medical
products
Deep understanding of medical imaging, computer vision, and model
validation in clinical contexts
Strong command of relevant regulatory frameworks, including FDA
510(k) and ISO 13485
Experience in a fast-paced, startup or growth-stage healthcare
environment is a plus
Keywords: VirtualVocations, Poway , Director of AI Medical Devices, Executive , Vista, California
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