Sr Manager, International Device Regulatory Affairs

Role: Lead international regulatory strategies for high-risk implantable medical devices, focusing on Japan, China, and Latin America, ensuring market access and compliance. Responsibilities: develop country-specific regulatory plans, manage submissions, liaise with global regulators, oversee product lifecycle activities, and monitor evolving international regulations; mentor staff and coordinate cross-functional teams including Quality, Clinical, and Medical Safety. Requirements: Bachelor’s degree (advanced degree preferred); 7+ years in Regulatory Affairs for Class III implantable devices, with at least 5 years in combination products; strong knowledge of international medical device regulations in targeted regions; proven leadership and cross-cultural collaboration skills; excellent communication and negotiation abilities. HighValue: Regulatory leadership for high-risk implantable device programs, international market approval, complex submissions, and lifecycle management across Japan, China, and Latin America. WorkSetup: Not specified.