Senior Specialist, Trade Compliance

Job Description

The Senior Trade Compliance Specialist is a member of the Trade Compliance Operations team and plays a key role in ensuring the timely, compliant import of goods into the United States in accordance with U.S. Customs and Border Protection (CBP) regulations, with particular focus on shipments that are also regulated by the U.S. Food and Drug Administration (FDA) for medical device products. This role manages daily customs clearance activities, coordinates with internal and external partners to resolve information requests and regulatory holds, and supports broker performance management, including the quarterly broker scorecard.

Job Duties

Customs Clearance Support

• Own a designated shipping lane, serving as the primary point of contact for broker requests within that lane.
• Respond to requests from the customs broker for additional information, conducting the research needed to provide accurate, timely answers that keep shipments moving.
• Maintain a tracker documenting new requests, clearance status with customs and FDA.
• Review shipping documents, to ensure accuracy, and work with internal or external stakeholders to obtain corrected or revised documentation when discrepancies or questions arise.

Regulatory Compliance

• Use internal databases to identify the correct FDA-required data and documentation based on the usage and type of material being imported, including applicable affirmation of compliance codes.
• Support compliance with FDA and other regulatory requirements, including responding to agency notices and coordinating internally to resolve them.
• Prepare and provide the customs broker with required supporting documentation, such as intended use letters, to support compliant entry.
• Support the Temporary Importation under Bond (TIB) process.

Ad Hoc Shipment Management (Non-PO, Non-Inventory)

• Own the intake and processing of ad hoc, non-PO/non-inventory shipments end-to-end, partnering with internal stakeholders to gather the information needed for classification and FDA review.
• Reconcile shipment documentation prior to release and ensure the customs broker has what's needed for clearance.
• Track shipments and coordinate with internal stakeholders and couriers to resolve exceptions.

Related Party Analysis

• Manage the end-to-end Related Party Analysis process on a recurring (biannual) basis, partnering with the Transfer Pricing team to obtain up-to-date entity information and consolidating findings for submission to the customs broker.

Cross-Functional Coordination

• Serve as a key point of contact between internal teams and the customs broker, sharing status updates and aligning on priority shipments.
• Support broker relationship management by capturing meeting notes, providing regular updates on pending shipments during recurring broker meetings, and tracking performance metrics.
• Perform other duties as assigned.

Job Qualifications

Required:

• Minimum of 5-7 years of experience working with U.S. Customs regulations and partner government agency (PGA) requirements, with direct experience supporting FDA-regulated medical device imports strongly preferred.
• Strong critical thinking skills with a detail-oriented approach to reviewing shipment and compliance documentation.
• Excellent research and analytical skills.
• Excellent written and verbal communication skills.
• A proactive, self-driven communicator w