This role is crucial for ensuring the development, manufacture, and distribution of medical devices in compliance with corporate policies, U.S. Food and Drug Administration regulations, ISO 13485, the Canadian Medical Device Regulations (CMDR), the EU Medical Device Regulation, Japanese Pharmaceutical Affairs Law, and other applicable regulatory agencies. Leads with authority and influences globally across manufacturing and distribution facilities and cross functional stakeholders including but not limited to quality, product development, process technology, operations, supply chain, procurement, regulatory affairs, finance, and human resources.