Regulatory Affairs Manager, Medical Devices

Noctrix Health in Pleasanton, CA seeks an experienced Manager, Regulatory Affairs to lead regulatory activities for medical devices across development, registrations, and post-market compliance. Hybrid, full-time role reporting to Senior VP Clinical & Regulatory Affairs, based at our Pleasanton headquarters. The ideal candidate will manage FDA submissions (510(k) and international registrations), maintain registrations, review labeling, and coordinate cross-functional teams to ensure timely,