Not specified (assumed hybrid or onsite based on industry norms)
Fda medical device import requirements
Ace entry submissions and troubleshooting
Resolution of fda detentions and noas
Medline Industries is seeking a Manager of Regulatory Trade Compliance, responsible for ensuring compliant importation of FDA-regulated medical devices and kits into the U.S. The position demands expertise in FDA import requirements, data integrity, and collaboration across departments to streamline compliance processes
Job Summary
The role serves as the primary bridge between Regulatory Affairs, Imports/Logistics, Legal, and Corporate Compliance to ensure accurate FDA import data.
The position is responsible for owning the end-to-end process for FDA import compliance with a strong focus on ACE entry requirements and medical kit imports.
Medline Industries offers a competitive total rewards package including health insurance, 401(k) contributions, and paid time off for eligible employees.
Matching Summary
Match Score: 85
Medline Industries is seeking a Manager of Regulatory Trade Compliance, responsible for ensuring compliant importation of FDA-regulated medical devices and kits into the U.S. The position demands expertise in FDA import requirements, data integrity, and collaboration across departments to streamline compliance processes.
Salary
Base: $116,000.00 - $174,000.00 Annual; Bonus/Equity: Eligible for bonus/incentive; Benefits: Health insurance, life/disability, 401(k), PTO
Skills & Requirements
Must-have
FDA medical device import requirements
ACE entry submissions and troubleshooting
Resolution of FDA detentions and NOAs
Medical kit regulatory status determination
SOP development for import compliance
Nice-to-have
Customs Broker License or trade certification
Experience with SAP GTS systems
People management experience
Direct interaction with FDA officers
Background in enterprise governance
Key Requirements
Bachelor's degree in Regulatory Affairs or related field
Minimum 5 years of experience in FDA-regulated industry
Demonstrated experience managing import compliance for medical kits