Manager, Regulatory Trade Compliance

Medline Industries, LP

Regulatory Trade Compliance Manager responsible for FDA import compliance processes. Collaborating with Regulatory Affairs, Imports, Legal, and Corporate teams for compliance across medical devices.

Posted 4/16/2026full-timeRemote • Illinois • 🇺🇸 United StatesMid-LevelSenior💰 $116,000 - $174,000 per yearWebsite

About the role

Key responsibilities & impact

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 through the Automated Commercial Environment (ACE).
Oversee and validate FDA entry data elements.
Act as the escalation point for complex FDA import questions and compliance determinations.
Design and implement standardized processes to ensure consistency of FDA-critical data.
Develop and maintain SOPs, work instructions, and internal controls related to FDA import compliance.
Serve as the primary Regulatory Affairs contact for FDA detentions and Notices of FDA Action (NOAs).

Requirements

What you’ll need

Bachelor’s degree in Regulatory Affairs, Life Sciences, International Trade, Supply Chain, or a related field
Minimum 5 years of experience in FDA-regulated industry
Demonstrated experience creating and implementing business processes and governance controls
Experience managing import compliance for medical kits / convenience kits
FDA medical device import and registration requirements
ACE entry submissions and troubleshooting
Resolution of FDA detentions and Notices of Action
Experience translating regulatory requirements into operational processes

Benefits

Comp & perks

health insurance
life and disability
401(k) contributions
paid time off
Employee Assistance Program
Employee Resource Groups
Employee Service Corp

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

FDA import requirementsACE submissionsregulatory guidanceFDA entry data validationSOP developmentbusiness process implementationimport compliance managementmedical device registrationregulatory requirements translation

Soft Skills

subject matter expertiseproblem-solvingcommunicationleadershiporganizational skills

Certifications

Bachelor’s degree in Regulatory AffairsBachelor’s degree in Life SciencesBachelor’s degree in International TradeBachelor’s degree in Supply Chain