Director of AI Medical Devices

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

Apr 24, 2025 - 20:37

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