Global Trade Compliance Manager

Position Summary:

The Global Trade Compliance Manager is responsible for the oversight, administration, and continuous improvement of the Company's global trade compliance program, including export controls, economic sanctions, restricted-party screening, import and customs compliance, licensing, and transaction due diligence.

This position serves as a key subject-matter expert and business partner, ensuring the Company's international sales, shipments, services, technology transfers, and third-party relationships comply with applicable U.S. and international trade requirements. The Manager partners closely with Legal, Regulatory Affairs, Quality, Supply Chain, Logistics, Finance, Engineering, Service, Sales, international subsidiaries, and distributors to identify and manage trade-compliance risks while supporting global business operations.

Duties & Responsibilities:

Restricted-Party and Sanctions Compliance

• Own and administer the Company's restricted-party and sanctions screening program, including screening protocols, alert resolution, ownership analysis, enhanced due diligence, escalation procedures, rescreening, and transaction holds.
• Oversee screening against applicable U.S. and international sanctions and restricted-party lists, including those maintained by OFAC, BIS, the U.S. Department of State, United Nations, European Union, and United Kingdom.
• Independently evaluate complex screening alerts, potential matches, ownership concerns, sanctioned-country transactions, and other higher-risk matters.
• Establish and maintain appropriate screening controls, documentation standards, escalation procedures, and monitoring to ensure screening is completed at required transaction milestones.

End-Use, End-User and Diversion Compliance

• Evaluate transactions involving customers, distributors, intermediaries, end users, end uses, destinations, government entities, and higher-risk jurisdictions for export-control, sanctions, diversion, and licensing risks.
• Review transactions for prohibited end uses and end users, military or intelligence applications, unauthorized territories, transshipment concerns, and other export-control risks.
• Investigate trade-compliance red flags, including unusual routing, third-party payments, unidentified end users, inconsistent customer information, freight-forwarder arrangements, and destinations near sanctioned jurisdictions.
• Establish requirements for end-use statements, end-user certifications, non-diversion certifications, sanctions representations, and other compliance documentation as appropriate.
• Partner with Legal on transactions involving sanctioned or embargoed jurisdictions, restricted parties, government or state-owned entities, and other elevated-risk matters.

Export Controls, Classification, and Licensing

• Serve as a subject-matter expert on U.S. export controls, including the Export Administration Regulations (EAR), export classifications, licensing requirements, and technology controls.
• Own and maintain ECCNs, EAR99 determinations, Schedule B classifications, and other export-control data for medical devices, lasers, components, software, technology, and technical data.
• Determine export and reexport licensing requirements and manage or support license applications, license exceptions, classification requests, government authorizations, and associated compliance obligations.
• Evaluate and implement controls governing the transfer or release of technology and technical data to foreign employees, affiliates, suppliers, contract manufacturers, and service providers, including technology-control plans where required.

Medical Device Import and Export Compliance

• Provide trade-compliance oversight for international movement of medical devices, lasers, components, accessories, software, service parts, demonstration and clinical equipment, returns, repairs, refurbished devices, and intercompany transfers.
• Provide guidance for commercial shipments, demonstration and evaluation equipment, trade shows, physician training, clinical trials, regulatory testing and samples, loaner equipment, warranty returns, complaint investigations, and contract manufacturing.
• Partner with Regulatory Affairs to ensure international transactions are consistent with applicable product registrations, labeling, manufacturer information, intended use, and authorized destinations.
• Support resolution of shipments held or detained by Customs, FDA, or other government agencies.

Customs and Import Compliance

• Own and maintain HTS classifications, country-of-origin determinations, customs valuation, and other import-related master data and compliance requirements.
• Oversee customs documentation, FDA and Partner Government Agency requirements, customs broker activities, and periodic audits of customs entries and declarations.
• Investigate and resolve customs discrepancies, classification questions, valuation issues, and other import-related compliance matters.
• Support temporary imports, returned-goods treatment, repairs, duty drawback, free-trade agreements, and other available duty-management programs.
• Monitor customs broker and freight-forwarder compliance and performance.

Trade Compliance Program Management

• Develop, maintain, and continuously improve global trade-compliance policies, procedures, internal controls, work instructions, screening protocols, escalation processes, and recordkeeping requirements.
• Conduct periodic risk assessments, audits, and compliance monitoring to evaluate program effectiveness, identify control gaps, and implement corrective actions.
• Oversee trade-compliance data, workflows, screening rules, and controls within ERP, Global Trade Management, restricted-party screening, and other applicable systems.
• Establish and monitor compliance metrics related to screening, transaction holds, classifications, licensing, audits, and corrective actions.
• Monitor changes in sanctions, export controls, customs, and other applicable trade regulations and assess their impact on Company products and global operations.
• Support investigations, government inquiries, voluntary disclosures, corrective actions, and remediation activities in partnership with Legal.
• Serve as a trade-compliance advisor to Legal, Regulatory Affairs, Quality, Supply Chain, Logistics, Finance, Engineering, Service, Sales, and other business functions.
• Develop and deliver trade-compliance training and integrate compliance requirements into new products, markets, distributors, suppliers, contract manufacturers, acquisitions, and other strategic initiatives.
• Provide oversight and guidance to customs brokers, freight forwarders, consultants, and other trade-compliance service providers.
• Other duties as needed or required.