Manager Regulatory Trade Compliance

📋 Description

• • The Regulatory Trade Compliance Manager ensures compliant and efficient importation of medical devices, medical kits, and other FDA-regulated products into the United States, serving as the primary bridge between Regulatory Affairs, Imports/Logistics, Legal, and Corporate Compliance to align FDA import data and processes across internal systems, suppliers, and customs brokers.
• • Day to day, the role involves serving as the Regulatory Affairs subject matter expert for FDA import requirements and ACE submissions, providing regulatory guidance to Imports and Logistics teams, overseeing and validating FDA entry data elements, acting as the escalation point for complex FDA import questions, and owning end-to-end FDA import compliance processes with a focus on ACE entry requirements, medical kit imports, and resolution of FDA Notices of Action.
• • The role is part of Medline Industries, LP, a growing worldwide organization dedicated to creating an inclusive workplace where employees feel they belong and can grow their career, with a commitment to diversity, equity, and belonging initiatives.
• • In this role, the person can develop deep expertise in FDA import compliance for medical devices and kits, lead process standardization and governance initiatives across enterprise systems, build professional relationships with FDA import reviewers, and drive continuous improvement in detention reduction and data integrity while gaining experience in cross-functional collaboration with Legal, Quality, Sourcing, and Product Development teams.