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O&M Halyard · 4 days ago

Senior Trade Compliance Analyst

Richmond, VA

Full-time

Onsite

Mid, Senior Level

$115K/yr - $130K/yr

3+ years exp

Owens & Minor is a Fortune 500 company that plays a critical role in the healthcare process, providing integrated technologies, products, and services. They are seeking a Senior Trade Compliance Analyst to ensure compliant and efficient movement of goods across borders, particularly focusing on U.S. regulatory requirements and managing classification, documentation, and regulatory filings.

Health CareHospital

Responsibilities

U.S. Import & Regulatory Compliance (CBP & FDA)

Prepare, review, and approve import documentation (commercial invoices, packing lists, COO, certificates, SDS, and device documentation) to ensure CBP compliance (19 CFR)

Maintain compliant HTS classification; validate duty/tax impacts, PGA flags (FDA, EPA, etc.), and country of origin determinations

Coordinate with customs brokers on entry filing accuracy (including FDA Affirmations of Compliance, product codes, intended use codes, and device listing numbers)

Support FDA regulatory activities for medical devices (e.g., establishment registration, device listing updates, proprietary names, and owner/operator linkages under 21 CFR Part 807)

Manage admissibility issues (e.g., line holds, exams, detentions) and assist with responses to CBP/FDA inquiries

Monitor changes in U.S. tariff schedules, rulings, and guidance impacting product portfolios

Ensure documentation and procedures align with Central American customs framework (e.g., CAUCA/RECAUCA) and national requirements (e.g., Aduanas Honduras / SAR)

Coordinate import/export operations with LATAM brokers and forwarders; validate local tariff classification, valuation, origin, and licensing/permitting requirements

Support free trade agreements and preferential origin claims where applicable (e.g., DR‑CAFTA rules of origin and certificates)

Track LATAM regulatory nuances (e.g., health authority registrations where required, labeling, Spanish‑language documentation)

Resolve clearance issues, discrepancies, and post‑entry corrections; maintain audit‑ready records per local retention requirements

Maintain accurate product master data for HTS, ECCN (as applicable), unit of measure, COO, valuation notes, and regulatory flags in ERP/TMS

Coordinate SKU onboarding and attribute changes with Product Management, Quality/Regulatory, and IT

Administer SOPs/work instructions for import/export processes, broker management, record‑keeping, and regulatory filings

Conduct internal file reviews and broker audits; remediate gaps and implement preventive controls

Deliver training to operations/warehouse/customer service teams on documentation accuracy, incoterms, and customs/FDA requirements

Drive cycle‑time reduction for customs clearance and FDA admissibility

Implement data‑driven improvements (e.g., standard templates, document automation, and dashboards)

Report KPIs (see below), analyze trends, and lead corrective actions

Qualification

U.S. Import ComplianceFDA Regulatory RequirementsHTS ClassificationERP/TMS ProficiencyLATAM Trade ComplianceStakeholder CommunicationData DisciplineSpanish LanguageAttention to DetailProblem SolvingOwnership & Urgency

Required

3–5+ years in import/export and trade compliance, with hands‑on experience in LATAM (preferably Honduras) and U.S. CBP/FDA processes

Demonstrated proficiency with HTS classification (U.S. and LATAM), COO, valuation

CBP entry processes, broker management, and PGA coordination

FDA medical device requirements: product codes, intended use codes, Affirmations of Compliance, device listing and establishment registration (21 CFR Part 807)

Strong ERP/TMS familiarity (SAP, Oracle, or similar) and document control discipline

Language: English; Spanish a Plus, bit not essential

Excellent attention to detail, organization, and stakeholder communication

Preferred

Bachelor's degree in engineering, international business, Supply Chain Management, or other Supply Chain related discipline with strong preference to advanced degrees in relevant discipline or equivalent experience Trade compliance certifications (e.g., CTCS, L2/CCO), or customs broker/brokerage experience

Prior work with ANVISA/COFEPRIS/INVIMA or other LATAM health authorities (as applicable to the product portfolio)

Knowledge of EAR/ITAR basics, export screening, and denied party checks

Familiarity with CAUCA/RECAUCA frameworks and Honduran customs procedures

Experience creating SOPs, running audits, and leading corrective actions