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.
Skills Required
- Minimum of 5 years of experience in trade compliance, including import/export operations
- Strong knowledge of trade sanctions and export control in China, US, UK and EU
- Strong knowledge of US export controls and international trade sanctions regimes
- Proficiency in MS Office, particularly Excel
- Fluent English, both written and spoken
What We Do
Ortho Clinical Diagnostics (Nasdaq: OCDX) is one of the world’s largest pure-play in vitro diagnostics (IVD) companies dedicated to transforming patient care. More than 800,000 patients across the world are impacted by Ortho’s tests each day. Because Every Test is a Life, Ortho provides hospitals, hospital networks, clinical laboratories and blood banks around the world with innovative technology and tools to ensure test results are fast, accurate, and reliable. Ortho's customized solutions enhance clinical outcomes, improve efficiency, overcome lab staffing challenges and reduce costs. From launching the first product to determine Rh+ or Rh- blood type, developing the world’s first tests for the detection of antibodies against HIV and hepatitis C, introducing patented dry-slide technology and marketing the first U.S. Food and Drug Administration-authorized high-volume antibody and antigen tests for COVID-19, Ortho has been a pioneering leader in the IVD space for over 80 years. The company is powered by Ortho Care, an award-winning, holistic service and support program that ensures best-in-class technical, field and remote service and inventory support to laboratories in more than 130 countries and territories around the globe.





