Job Description

The Vice President of Trade Compliance reports to the SVP Planning and Logistics and is responsible for establishing, governing, and enforcing the company’s global trade compliance framework for medical devices, instruments, accessories, capital equipment, service parts, software, and indirect materials. The role ensures full legal compliance with all applicable import, export, customs, sanctions, and trade regulations while supporting uninterrupted patient care, regulatory approvals, and global commercial operations. The position balances regulatory rigor with operational continuity in a highly regulated environment where delays and enforcement actions may impact healthcare delivery.

JOB RESPONSIBILITIES:

• Continue to build and lead a global trade compliance organization.
• Establish training programs tailored to manufacturing, service, commercial teams, distributors, logistics providers, and customs brokerage.
• Direct responsibility for compliance with inbound materials, manufacturing cross-border transactions, and finished goods into markets.
• Ensure escalation, issue management, and document controls.
• Serve as the primary interface with customs and export control authorities, health authorities, and trade regulators.
• Represent the company in industry groups addressing medical device trade issues.
• Manage relationships with brokers, consultants, outside counsel, and regulatory advisors.
• Oversee trade compliance systems integrated with ERP, WMS, TMS, and Global Trade Management platforms.
• UDI, lot, serial, and device history record data.
• Ensure accuracy of HS codes, ECCNs, valuation, and origin, and the sku and serialized device level.
• Drive automation to reduce clearance delays and improve audit readiness.

REQUIRED QUALIFICATIONS and EXPERIENCE:

Strategic Leadership:

• Define and own the trade compliance strategy across R&D, manufacturing, service, and commercial distribution.
• Proactively advise executive leadership on trade risks affecting business continuity, and service programs.
• Assess geopolitical, sanctions, and regulatory developments impacting medical device supply chains.

Regulatory and Medical Device Compliance:

• Ensure compliance with trade regulations as they apply to finished goods, capital equipment, service parts, digital health components, clinical trial materials, samples, etc.
• Partner with Regulatory Affairs and Quality to ensure trade compliance does not compromise regulatory approvals, UDI requirements, or product traceability.
• Understanding FDA-regulated products and global equivalents (EU MDR, UKCA, PMDA, NMPA, ANVISA, etc.).

Governance, Policy, and Risk Management:

• Establish and maintain global policies covering: HS classification, Valuation, ECCN determinations, Country-Of-Origins and substantial transformation analysis, Free Trade Agreements and preferential duty programs, sanctioned, and denied party screenings for institutions and distributors.
• Lead government audits, inquiries, and inspections related to customs and export controls.
• Oversee voluntary disclosures and corrective actions in coordination with Legal, Outside Counsel, and Quality.

Continuity of Care:

• Embed compliance into workflows including global manufacturing, field service, and logistics, repair networks, consignment, loaner, and emergency replacement programs.
• Ensure compliant execution of bonded movement, bonded warehouses, Free Trade Zones, and duty deferral programs.
• Enable tariff-mitigation strategies without risking regulatory violations or product holds.

Track Record:

• History of zero material trade violations, on-time clearance of critical device and service parts, successful audits with customs, effective tariff and duty optimization, and institution of systems and networks.

REQUIRED EDUCATION and TRAINING:

• Proven leadership at the Vice President and Director levels of global and regional compliance teams.
• Demonstrated experience supporting regulated medical device or life science supply chains.
• BS in Law, International Trade, Business, Supply Chain / Logistics, or related field
• 15+ years of experience in global trade compliance, customs, or export controls
• Trade or Custom Certifications (LCB, CCS, CUSECI, or equivalent)