Manager Regulatory Trade Compliance

Job description

Job Summary The Regulatory Trade Compliance Manager is responsible for ensuring compliant and efficient importation of medical devices, medical kits, and other FDA-regulated products into the United States. This role serves as the primary bridge between Regulatory Affairs, Imports/Logistics, Legal, and Corporate Compliance to ensure that FDA import data and processes are accurate, consistent, and aligned across all internal systems, contract manufacturers, suppliers, and customs brokers. The position is being established to strengthen FDA import compliance and reduce detentions by creating standardized governance processes, improving data integrity, and developing effective working relationships with FDA import reviewers. The individual will own the end-to-end process for FDA import compliance, with a strong focus on ACE entry requirements, medical kit imports, and resolution of FDA Notices of Action. Job Description: MAJOR RESPONSIBILITIES: - Serve as the Regulatory Affairs subject matter expert for FDA import requirements and ACE submissions for medical devices and medical kits. - Provide regulatory guidance to Imports and Logistics teams to ensure accurate FDA data transmission...