Regulatory Affairs Manager, Medical Devices (Global)

Real Staffing seeks an experienced Regulatory Affairs Manager to join a growing medical device organization focused on innovative healthcare technologies. You will develop regulatory strategies, manage submissions, and ensure global compliance to bring products to market.

The role requires 5+ years in regulatory affairs within medical devices or IVD, hands-on FDA 510(k) and CE Marking experience, and strong knowledge of ISO 13485, MDR/IVDR, and related standards.