• Communicate and interface directly with regulatory authorities to ensure product approvals are achieved in a timely manner, if needed. • Communicate Country/region-specific regulatory requirements to the Regulatory Specialist/Regulatory Science team leaders and assist with the regulatory strategies. • Obtain and maintain product approval, and serve as a communication liaison on regulatory issues between the Cook manufacturer and the Cook International Local Office and/or Cook Distributor. • Plan and prepare regulatory submissions for new products, product changes, and re-registrations as required for the specific countries/regions. • Maintain registration information (license numbers, expiration dates, etc.) and obtain re-registration approvals in advance of license expirations to ensure no disruption in product availability. • Perform translation activities. • Provide support to currently marketed products as necessary including input on change requests, etc. • Collaborate with Regulatory Scientific Affairs on all high risk devices and new technologies. • Collaborate with the Clinical Functional Unit on projects requiring the collection of clinical data. • Provide support to currently marketed products as necessary including input on change requests, etc. • Maintain and organize appropriate regulatory records to demonstrate compliance with applicable regulations. • Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.