Job Description

The Opportunity

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most – home to hospital, lab to clinic.

Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.

The Responsibilities:

• Collaborate with business leaders, the Legal team, and the Global Trade Compliance team to develop and implement trade compliance processes, SOPs, internal control plans, training programs, and initiatives across the JAPAC region. Ensure QO’s compliance with local, U.S., EU, and UK regulations governing the import and export of goods.
• Monitor and assess regulatory changes affecting QO’s supply chain. Provide analysis and guidance on regulatory changes, interpreting import and export control requirements across JAPAC, and proactively implement process updates when needed.
• Identify, assess, and mitigate import/export risks across the region. Drive process improvements and automation initiatives using continuous improvement methodologies to enhance trade compliance.
• Identify compliance gaps and lead corrective action efforts.
• Oversee accurate assignment of classifications, and Dual-Use codes for goods. Determine preferential/non-preferential Country of Origin based on bill of materials.
• Lead and oversee daily trade operations, acting as the regional subject matter expert to ensure alignment with global compliance standards.
• Serve as a strategic advisor to internal and external stakeholders, ensuring timely and compliant resolution of trade-related issues.
• Resolve compliance issues affecting product flows, especially time-sensitive shipments related to QO supply.
• Work directly with customs brokers and internal stakeholders to ensure all transactions comply with international trade laws through effective deployment and integration of internal controls.
• Manage export compliance activities, including export licenses, diversion risk assessments, and export declarations.
• Maintain accurate trade data for all products, including ECCNs, HTS codes, Country of Origin, valuation, and invoice accuracy to ensure timely and compliant customs clearance.
• Support internal and external audits, customs inquiries, and risk assessments.
• Identify cost optimization opportunities and drive the implementation

Internal Customers:

• Logistics
• Legal
• Tax
• Finance
• Procurement
• External Operations

External Customers:

• Customs Brokers
• Suppliers

Required Skills:

• Minimum of 5 years of experience in trade compliance, including import/export operations, regulatory analysis, and classification activities.
• Strong knowledge of the trade sanctions and export control in China, the US, UK and EU, Harmonized System (HS), General Rules of Interpretation (GRIs), and Free trade Agreements.
• Strong knowledge of US export controls (EAR/ITAR), EU/UK/China Dual-Use regulations, and international trade sanctions regimes.
• Proficiency in MS Office, particularly Excel.
• Fluent English, both written and spoken.
• Candidates with less experience may be considered for a Trade Compliance Analyst position.

Preferred Skills:

• Bachelor’s degree in a related field such as Law, Logistics, or Finance, or equivalent professional experience.
• Hands-on experience with U.S. export controls and sanctions regulations (e.g., EAR, OFAC).
• Prior experience in the medical device or healthcare sector, with knowledge of industry-specific trade compliance requirements.
• Proficiency in SAP or similar ERP systems, particularly in managing trade compliance-related data and workflows.