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 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, continuing education & training, and tremendous potential with a growing worldwide organization.
The anticipated salary range for this position:
$116,000.00 - $174,000.00 Annual
The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.
Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here.
We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here.
Medline Industries, LP 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, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.