Enovis Brisbane seeks an experienced Senior Regulatory Affairs Specialist to lead global regulatory strategies for orthopedic-enabled technologies, including SaMD. You will develop submissions for US, EU and Australia and guide cross-functional teams to ensure compliant product launches.
Ideal candidates have 5+ years in medical devices, robust knowledge of ISO 13485/14971 and 510(k)/CE procedures, and a proven ability to manage regulatory activities across the product lifecycle while adapting