Manager Regulatory Trade Compliance
Medline, Chicago, IL, United States
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 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.
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 through the Automated Commercial Environment (ACE).
Oversee and validate FDA entry data elements including FDA Product Codes, Intended Use Codes, Affirmations of Compliance (AofC), Establishment Registration Numbers, Medical Device Listing (MDL) numbers, Manufacturer and importer identifiers.
Act as the escalation point for complex FDA import questions and compliance determinations.
Serve as the process owner for FDA import data integrity across the enterprise.
Design and implement standardized processes to ensure consistency of FDA-critical data across Regulatory Affairs systems, ERP and master data systems, Trade compliance platforms, Broker instructions, Supplier and contract manufacturer documentation.
Establish formal change-control processes to ensure that product updates, new listings, or regulatory changes are reflected in import data prior to shipment.
Develop and maintain SOPs, work instructions, and internal controls related to FDA import compliance.
Act as the internal expert on FDA import requirements for convenience kits, including determination of kit regulatory status, assignment of appropriate product codes, component-level listing considerations, multi-component admissibility requirements.
Partner with Product Development, Sourcing, and Quality to ensure new or revised kits are structured and documented in a manner that supports FDA admissibility.
Serve as the primary Regulatory Affairs contact for FDA detentions and Notices of FDA Action (NOAs). Lead root cause analysis and corrective actions to prevent recurrence of detentions.
Partner with the Imports team to investigate and resolve FDA entry issues, including incorrect or inconsistent product codes, outdated or missing device listings, data discrepancies, supplier documentation gaps.
Develop professional rapport with FDA import reviewers and compliance officers to facilitate timely resolution of entry reviews and questions. Track, trend, and report FDA detention metrics and drive continuous improvement initiatives.
Partner with suppliers and contract manufacturers to ensure understanding of U.S. FDA import requirements.
Support onboarding of new suppliers from an FDA import compliance perspective and ensure readiness prior to first shipment.
Collaborate closely with Legal and Corporate Compliance teams to establish and maintain an enterprise governance framework for FDA import compliance.
Participate in internal audits, compliance reviews, and investigations related to import activities.
Minimum Job Requirements
Education
Bachelor’s degree in Regulatory Affairs, Life Sciences, International Trade, Supply Chain, or a related field
Equivalent combination of education and experience will be considered
Certification / Licensure Work Experience
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
Knowledge / Skills / Abilities
FDA medical device import and registration requirements
ACE entry submissions and troubleshooting
Resolution of FDA detentions and Notices of Action
Ability to analyze FDA entry failures and determine regulatory root causes
Experience translating regulatory requirements into operational processes
Preferred Job Requirements
Certification / Licensure
Customs Broker License or trade compliance certification
Work Experience
People management experience
Experience interacting directly with FDA import compliance officers
Experience with SAP GTS or similar trade compliance systems
Background partnering with Legal and Compliance on governance initiatives
Knowledge / Skills / Abilities
Experience supporting FDA inspections or audits
Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package and opportunities for continuing education and professional growth. Medline is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, or any other characteristic protected by law.
Medline Industries, LP is an equal opportunity employer. The Anticipated Salary Range for this position is $116,000.00 - $174,000.00 annually. The actual salary will vary based on location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible.
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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 through the Automated Commercial Environment (ACE).
Oversee and validate FDA entry data elements including FDA Product Codes, Intended Use Codes, Affirmations of Compliance (AofC), Establishment Registration Numbers, Medical Device Listing (MDL) numbers, Manufacturer and importer identifiers.
Act as the escalation point for complex FDA import questions and compliance determinations.
Serve as the process owner for FDA import data integrity across the enterprise.
Design and implement standardized processes to ensure consistency of FDA-critical data across Regulatory Affairs systems, ERP and master data systems, Trade compliance platforms, Broker instructions, Supplier and contract manufacturer documentation.
Establish formal change-control processes to ensure that product updates, new listings, or regulatory changes are reflected in import data prior to shipment.
Develop and maintain SOPs, work instructions, and internal controls related to FDA import compliance.
Act as the internal expert on FDA import requirements for convenience kits, including determination of kit regulatory status, assignment of appropriate product codes, component-level listing considerations, multi-component admissibility requirements.
Partner with Product Development, Sourcing, and Quality to ensure new or revised kits are structured and documented in a manner that supports FDA admissibility.
Serve as the primary Regulatory Affairs contact for FDA detentions and Notices of FDA Action (NOAs). Lead root cause analysis and corrective actions to prevent recurrence of detentions.
Partner with the Imports team to investigate and resolve FDA entry issues, including incorrect or inconsistent product codes, outdated or missing device listings, data discrepancies, supplier documentation gaps.
Develop professional rapport with FDA import reviewers and compliance officers to facilitate timely resolution of entry reviews and questions. Track, trend, and report FDA detention metrics and drive continuous improvement initiatives.
Partner with suppliers and contract manufacturers to ensure understanding of U.S. FDA import requirements.
Support onboarding of new suppliers from an FDA import compliance perspective and ensure readiness prior to first shipment.
Collaborate closely with Legal and Corporate Compliance teams to establish and maintain an enterprise governance framework for FDA import compliance.
Participate in internal audits, compliance reviews, and investigations related to import activities.
Minimum Job Requirements
Education
Bachelor’s degree in Regulatory Affairs, Life Sciences, International Trade, Supply Chain, or a related field
Equivalent combination of education and experience will be considered
Certification / Licensure Work Experience
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
Knowledge / Skills / Abilities
FDA medical device import and registration requirements
ACE entry submissions and troubleshooting
Resolution of FDA detentions and Notices of Action
Ability to analyze FDA entry failures and determine regulatory root causes
Experience translating regulatory requirements into operational processes
Preferred Job Requirements
Certification / Licensure
Customs Broker License or trade compliance certification
Work Experience
People management experience
Experience interacting directly with FDA import compliance officers
Experience with SAP GTS or similar trade compliance systems
Background partnering with Legal and Compliance on governance initiatives
Knowledge / Skills / Abilities
Experience supporting FDA inspections or audits
Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package and opportunities for continuing education and professional growth. Medline is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, or any other characteristic protected by law.
Medline Industries, LP is an equal opportunity employer. The Anticipated Salary Range for this position is $116,000.00 - $174,000.00 annually. The actual salary will vary based on location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible.
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