AI Regulatory Lead for Imaging SaMD

A leading medical imaging technology firm in Danvers, MA, is seeking an AI Regulatory Manager to lead regulatory strategies for AI/ML medical imaging devices. The role requires 8+ years of regulatory affairs experience, including managing software as a medical device (SaMD), and a strong understanding of FDA and EU regulations. The position involves collaboration with various departments to secure timely product approvals and ensuring compliance with global standards. A comprehensive benefits package is offered, including medical, dental, and generous paid time off. #J-18808-Ljbffr