US Import Compliance Analyst

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.

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.