Director of Global Regulatory Affairs

A company is looking for a Director, Global Regulatory Affairs & Intelligence. Key Responsibilities Drive end-to-end regulatory strategy from concept through commercialization, including submissions and approvals for medical devices and SaMD products Manage interactions with regulatory authorities and ensure compliance with evolving global requirements Lead a regulatory intelligence program and mentor a high-performing regulatory team while optimizing internal workflows Required Qualifications Bachelor's degree in a STEM field; advanced degree preferred 10+ years of regulatory affairs experience with Class II medical devices and SaMD Deep expertise in global regulatory frameworks and successful navigation of complex pathways Proven track record managing regulatory authority interactions with favorable outcomes Experience leading regulatory teams in fast-paced, innovation-driven environments

Created: 2026-03-05