Global Regulatory Intelligence, Senior Project Manager

Role: Senior Project Manager, Global Regulatory Intelligence, focusing on monitoring and analyzing international regulatory changes to ensure compliance and inform strategic decisions in the medical device sector. Responsibilities: track, interpret, and assess global regulations, standards, and legislation; advise internal teams on compliance impacts; manage regulatory intelligence tools; collaborate with industry and regulatory bodies; and support process improvements and regulatory documentation updates. The role involves cross-functional influence, mentorship, and strategic guidance within Regulatory Affairs, Quality, Clinical, and Operations. Requirements: Bachelor's in science, engineering, or related field; 4+ years in regulatory, quality, or compliance roles within medical devices or biologics; experience with FDA Class II/III and EU Class IIa/IIb or III devices; proficiency with regulatory databases and software; strong analytical, communication, organizational, and project management skills; ability to interpret complex regulations, manage multiple projects, and collaborate across teams. Preferred: experience with US FDA, Notified Bodies, Health Canada, international submissions, and cardiovascular devices or human tissues. High-value specifics include global regulatory landscape, medical devices, and lifecycle management. Work setup details are not specified.