The Position:

We are seeking a highly skilled and experienced Global Import/Export Specialist with a strong background in clinical samples and global IVD regulations compliance. You will be responsible for managing and coordinating the international import and export of human clinical samples materials and diagnostic products manufactured by Veracyte Inc, ensuring compliance with all relevant regulations and standards. You will liaise with internal departments including regulatory, legal, clinical samples affairs, R&D and others, and should be comfortable in your expertise of trade compliance. 

Seeking candidates based in San Diego or Los Angeles with occasional travel to San Diego. 

Responsibilities:

• Ensure compliance with global import/export regulations, including European Union IVDR, US FDA, and other relevant health authorities, as applicable.
• Prepare, review, and manage all necessary documentation for import/export activities, including invoices, packing lists, certificates of origin, and regulatory submissions.
• Coordinate with customs brokers, small parcel shippers, freight forwarders, and regulatory agencies to facilitate smooth customs clearance processes.
• Collaborate with internal and external stakeholders to ensure timely and efficient movement of goods across international borders.
• Identify and mitigate risks related to import/export activities, including potential delays, regulatory changes, and compliance issues.
• Conduct regular audits of import/export processes and maintain appropriate records and certificates to support regulatory inspections and reporting requirements.
• Provide training and support to internal teams on import/export regulations and best practices.
• Develop internal documentation and standard operating procedures for teams to understand and comply with global trade requirements and documentation. 

Who You Are:

• Bachelor’s degree in Supply Chain Management, International Business, Regulatory Affairs, or a related field. Advanced degree preferred.
• Minimum of 5 years of experience in global import/export operations, with a focus on clinical samples markets and applicable global IVD regulatory requirements.
• In-depth knowledge of global trade regulations, import/export regulatory requirements for IVDs, and other relevant standards.
• Strong organizational, communication, and problem-solving skills. Proficiency in ERP and compliance software is a must. 
• Professional certifications in import/export, such as Certified Customs Specialist (CCS) or Certified Export Specialist (CES), are a plus, National Customs Brokers & Forwarders Association of America (NCBFAA)