Senior Global Regulatory Affairs Lead — Medical Devices

Shifamed is seeking an experienced Regulatory Affairs Lead to oversee US, EU and Japan submissions for a class III medical device within Supira Medical’s portfolio. The role requires strategic planning, writing and submission management for IDE, PMA, EU Design Dossiers and Shonin, with close collaboration to the Supira regulatory team. Hybrid work from our Los Gatos, CA office, leading cross‑functional teams across Clinical, R&D and Quality to ensure compliant submissions and regulatory pathway