US Import Compliance Analyst

Posted Yesterday
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4 Locations
In-Office
75K-85K Annually
Mid level
Healthtech • Pharmaceutical
The Role
Supports U.S. import compliance across pharmaceutical and medical device operations. Responsibilities include managing customs brokers, reviewing shipment documentation, obtaining permits, maintaining trade databases, classifying products, managing records, conducting audits, analyzing import costs, supporting C-TPAT, coordinating launch projects, and delivering training. The role requires knowledge of U.S. customs, FDA, DEA, and ACE import coding requirements, along with supply chain concepts and SAP or Microsoft Office proficiency.
Summary Generated by Built In
Job SummaryThe US Import Compliance Analyst supports the supply chain activities across nine North American Marketing and Production Unit locations, spanning Fresenius Kabi (Pharma) and Fenwal (MedTech) divisions. The position ensures adherence to import regulations and formal control procedures, managing the timely and compliant flow of international shipments. Responsibilities include monitoring the performance of external customs brokerage partners, managing import documentation, obtaining necessary permits, and maintaining regulatory databases. The role also involves project management for high-profile U.S. import launches, cost analysis, and audit activities to ensure compliance, identify efficiencies, and provide training. It plays a key part in supporting the Supply Chain Security Program (C-TPAT) and continuous improvement initiatives.
*This position requires working onsite at one of our Distribution Centers (Pleasant Prairie, WI; Duncan, SC; or Las Vegas, NV), or at our Lake Zurich, IL US headquarters 3+ days per week. Priority will be given to candidates in Illinois or Wisconsin.
*This position is not eligible for visa sponsorship either now or in the future.
• Salary range $75,000-85,000 annually.
• Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
• Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

Responsibilities
  • The role provides support to Supply Chain activities for nine NAM Marketing Unit and NAM Production Unit locations across two divisions including Fresenius Kabi (Pharma) and Fenwal (Med Tech) Importer of Records (IORs).
  • Adhere to formal control procedures and training, ensuring import regulations are met within operations.
  • Monitor and audit the regulatory filing performance of external partners that provide import customs brokerage services on behalf of Fresenius Kabi.
  • Timely and organized management of the Import operational Inbox and service levels for internal and external customers.
  • Review pending shipment documentation to ensure compliance, provide instructions and approvals.
  • Assist in obtaining import permits (USDA, DEA, etc.) as required, in tandem with the appropriate departments.
  • Liaison with external customs brokers to respond to requests and ensure accuracy of import documentation and declarations.
  • Maintain local/regional Trade Master Data Management and Brokerage Parts Databases. Classify products and manage the various government agencies (i.e. Customs, FDA, USDA, DEA, EPA, etc.) with respect to customs transactions including HTS, ECCN, COO, FDA Affirmation of Compliance, PGA declarations, etc.
  • Manage record keeping processes and archive of import entry record packets.
  • Project Management supporting high profile new launch activities for US Imports including Demand Planning and Third-Party Manufacturing (TPM) departments.
  • Identification, escalation to management and support reviews of various US Agency regulatory inquiries.
  • Timely and accurate processing of internal monthly cost allocations for ACH payments of duties/fees with U.S. Customs related to importer of record accounts. Identification of anomalies and areas of compliance and cost saving opportunity.
  • Analyze international import brokerage and transportation network to identify, measure and present optimal balance between efficiencies, capacity, service requirements and costs.
  • Leverage internal and external data sources to develop cost and value tracking metrics. Prepare analytical results into meaningful written documentation and presentation material for management review.
  • Support functions relating to Supply Chain Security Program (C-TPAT) with US Customs.
  • Support and project management meeting company, program and regulatory change reviews.
  • Perform audits as they relate to import activities, both internally and externally.
  • Support relevant internal procedures and conduct import training.

Job Requirements

 

  • Bachelor’s degree preferred.
  • 3+ years of related experience required.
  • Knowledge of customs, FDA, and DEA regulations and processes.
  • Knowledge of FDA ACE import coding requirements is required.  Pharmaceutical and medical device experience is preferred.
  • Experience with both US import regulations operations.
  • Understanding of supply chain concepts as they relate to the importing of goods.
  • A high affinity to IT-based solutions and applications, in particular SAP and Microsoft Office.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Skills Required

  • 3+ years of related experience
  • Knowledge of customs, FDA, and DEA regulations and processes
  • Knowledge of FDA ACE import coding requirements
  • Experience with U.S. import regulations and operations
  • Understanding of supply chain concepts related to importing goods
  • Bachelor's degree
  • Pharmaceutical and medical device experience
  • Proficiency or affinity with IT-based applications, particularly SAP and Microsoft Office
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The Company
HQ: Bad Homburg v.d.Höhe
21,388 Employees

What We Do

Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion, and clinical nutrition. The company’s products and services are used for the therapy and care of critically and chronically ill patients. Its product portfolio comprises a range of highly complex biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs. Within biopharmaceuticals, Fresenius Kabi offers, among others, biosimilar drugs with a focus on autoimmune diseases and oncology. The company’s clinical nutrition offering includes a wide selection of enteral and parenteral nutrition products. In the segment of medical technologies, its offering includes vital disposables, infusions pumps, apheresis machines, cell therapy devices, and more. Fresenius Kabi puts essential medicines and technologies in the hands of people who help patients and finds the best answers to the challenges they face. Following its strategy “Vision 2026”, which is a key part of the #FutureFresenius program of the Fresenius healthcare group, the company is furthermore committed to increase efficiencies in the therapy and care of patients and improve access to high-quality healthcare around the globe. Fresenius Kabi aspires to be leading globally in its product segments – all for the benefit of patients, its customers, and its stakeholders. Fresenius Kabi Community Guidelines and User Information: https://www.fresenius-kabi.com/social-media-terms-conditions Imprint: https://www.fresenius-kabi.com/imprint

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