Sr. Logistics Specialist

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care. Overview Job Summary We are seeking an experienced Sr. Logistics Specialist with a strong background in import/export compliance to lead and manage domestic and international logistics operations in the life sciences industry. This role will oversee the end-to-end movement of highly regulated products domestically and across global borders while ensuring full compliance with U.S. and international trade, customs, and regulatory requirements, including those from FDA, CBP, IATA, and other global authorities. The ideal candidate will combine strategic logistics oversight with deep regulatory knowledge to build scalable processes, mitigate risk, and enable uninterrupted movement of life sciences products including biological materials, medical devices, reagents, and pharmaceuticals. Responsibilities Key Accountabilities Lead development and implementation of a comprehensive domestic and international trade compliance framework inclusive of SOP’s, Work Instructions, and strategies aligned with global regulations and company objectives. Ensure end-to-end compliance with U.S. and international import/export regulations, including EAR, ITAR, FDA, CBP, USDA-APHIS, and OFAC requirements. Implement and maintain a centralized Product Database for all imported/exported SKUs, classifying products using HTS codes and ECCNs, documenting Country of Origin, Manufacturer Registration ID’s, etc. to ensure accurate documentation, declarations, and shipment routing. Coordinate global shipments of life sciences products, including temperature-sensitive, hazardous, and biologically restricted materials, with appropriate cold-chain logistics. Manage relationships with customs brokers, freight forwarders, couriers, carriers, and third-party logistics providers while conducting regular business reviews and developing, implementing, and monitoring KPIs to drive performance, ensure compliance, and support timely shipment execution. Manage the transportation service provider network, including continuous improvement in supplier evaluation, qualification, onboarding, and performance management mechanisms while conducting business reviews and implementing/monitoring KPIs to drive performance, ensure compliance, and support timely shipment execution. Resolve domestic and international shipping issues proactively, coordinating with logistics partners and internal stakeholders to minimize delays and regulatory risk. Prepare, review, and maintain import/export documentation, including commercial invoices, packing lists, certificates of origin, shipping declarations, and internal shipment records. Partner with Regulatory Affairs, Quality, Legal, R&D, and other stakeholders to align logistics operations with regulatory and product-specific requirements. Monitor regulatory changes, assess business impact, develop SOPs, Work Instructions, and training programs, and facilitate internal/external audits — including CBP Focused Assessments and FDA logistics inspections — while implementing corrective actions. Plan and provide input for inbound/outbound freight and packaging budgets…

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