US Import Compliance Analyst

301095 Fresenius Kabi, LLC; Pleasant Prairie (WI); On-site; USD 75,000 - 85,000; Full time

Job summary

Fresenius Kabi USA is seeking an US Import Compliance Analyst to support nine NAM locations across Fresenius Kabi (Pharma) and Fenwal (MedTech). The role ensures adherence to import regulations, manages documentation, and supports regulatory audits and cost analysis.

The position can be onsite at a facility or Lake Zurich HQ, with responsibilities spanning training, risk mitigation, and continuous improvement in import processes.

Qualifications

• 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.

Responsibilities

• Monitor external customs brokerage partners' performance.
• Manage import documentation and permits.
• Maintain regulatory databases and records.
• Support high-profile US import launches and cost analysis.
• Audit activities to ensure compliance and identify efficiencies.
• Support Supply Chain Security Program (C-TPAT) and regulatory changes.
• Provide import training and knowledge sharing.
• Coordinate with brokers and internal departments for proper declarations.

Skills

Customs regulations

FDA regulations

DEA regulations

Import compliance

Education

Bachelor’s degree

Tools

SAP

Microsoft Office

Job description

Job Summary

The 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 Affiliation 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.

Fresenius Kabi is a global health care company that specializes in injectable medicines, biosimilars, and technologies for infusion, transfusion, and clinical nutrition. Our expansive portfolio of products and global network of science and manufacturing centers provide essential support for the care of critical and chronically ill patients.

With more than 41,000 employees worldwide, our dedicated team is united by our shared purpose: to put lifesaving medicines and technologies in the hands of people who care for patients - and to find answers to the challenges they face.

We call this purpose caring for life. Our U.S. headquarters is in Lake Zurich, Illinois and the company’s global headquarters is in Bad Homburg, Germany.