Medline Industries, LP

Manager, Regulatory Trade Compliance

Medline Industries, LP

full-time

Posted on:

Location Type: Remote

Location: Illinois • United States

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Salary

💰 $116,000 - $174,000 per year

About the role

  • 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

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

Tip: use these terms in your resume and cover letter to boost ATS matches.

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