The Role

As we continue to grow as one QuidelOrtho, we are seeking a Senior Manager Global Trade Compliance. The Senior Manager Global Trade Compliance will ensure compliance with global trade regulations for the import and export of medical devices, they will also provide Leadership and Direction to the Trade Compliance Team. This role will involve evaluating the effectiveness of global trade operations by evaluating scope of work on a regular basis and making changes when necessary. Creating accountability between the global trade function and external functions by defining dotted-line reporting structures to legal, Tax, corporate audit and Regulatory Affairs. Managing documentation, ensuring adherence to regulatory requirements, and providing support for the company's international shipments. The Senior Manager will work closely with internal departments such as Supply Chain, Logistics, Regulatory Affairs, and Legal, as well as external parties including customs authorities and freight forwarders and ead the Development of the Trade Compliance Program Globally.

This position can be in San Diego, CA.

Key Responsibilities

• Trade Compliance Program

  • Develop, implement, and maintain import/export compliance programs that adhere to U.S. and international regulations (e.g., FDA, U.S. Customs and Border Protection, EU MDR, and other relevant regulatory agencies).

  • Monitor regulatory changes in global trade laws and assess their impact on the company's operations.

  • Ensure compliance with relevant regulations, including the U.S. Export Administration Regulations (EAR), International Traffic in Arms Regulations (ITAR), and Office of Foreign Assets Control (OFAC).

• Documentation and Recordkeeping

  • Prepare, review, and manage all export and import documentation, including commercial invoices, packing lists, certificates of origin, and other trade-related paperwork.

  • Ensure accurate and timely filing of import/export declarations and other regulatory filings in accordance with applicable regulations.

• Product Classification and Valuation

  • Assign Harmonized Tariff Schedule (HTS) codes and Export Control Classification Numbers (ECCN) to medical devices and components.

  • Ensure accurate product valuation for customs purposes and maintain compliance with country of origin rules.

• Compliance Audits and Investigations

  • Conduct internal audits to ensure adherence to trade compliance policies and procedures.

  • Assist in investigations of trade compliance issues, providing analysis and recommendations for corrective actions.

• Training and Support

  • Provide training and guidance to internal teams (e.g., Logistics, Supply Chain) on trade compliance regulations, documentation, and best practices.

  • Serve as a liaison between the company and regulatory authorities, addressing any trade compliance inquiries.

• Vendor and Freight Forwarder Management

  • Coordinate with freight forwarders, customs brokers, and logistics partners to ensure smooth and compliant shipment processes.

  • Review and assess third-party compliance with trade regulations and corporate policies.

• Data Management

  • Maintain accurate records of import/export transactions, tariffs, and duty payments.

  • Utilize trade management software to track and report on trade compliance activities.

• People Management

  • Day to day oversight of the Team members.

  • Training plans, development plans and performance management of the team members.

KEY INTERACTIONS:

• Internal: Leaders of supply chain functions such as distribution, manufacturing, planning, and procurement, Leaders of regional commercial groups, customer services, and business units

• External: Suppliers

KNOWLEDGE & SKILLS

• Ability to articulate the analytics vision and team mission

• Ability to influence, engage senior supply chain and business leaders to promote analytics and secure support and funding

• Ability to build and manage teams with diverse backgrounds and skill sets, to empower and develop talent

• Basic proficiency in technology and advanced analytics to establish credibility with data science and engineering roles.

• Ability to develop and deliver training material

• Data gathering, and quantitative and qualitative data analysis, including business process metrics and measures linking to business KPIs

• High levels of personal integrity when conducting the professional affairs of the organization and dealing with sensitive and confidential data relating to risk and cost

• Meet deadlines and work under pressure, with limited supervision

• Well-organized and a high level of attention to detail

• Excellent knowledge of the end-to-end supply chain, with a clarity for understanding the importance and interdependencies associated with each stage of the process - Plan, Source, Make, Deliver

The Individual

Required:

• Bachelor's degree in International Trade, Business Administration, Supply Chain Management, or a related field.

• 5+ years of experience in import/export and trade compliance, preferably within the medical device or life sciences industry.

• Deep knowledge of global trade regulations, including FDA regulations for medical devices.

• Broader experience in Logistics or Supply Chain roles would be an advantage.

• Strong experience in developing and administering Trade Compliance training programs.

• Strong understanding of import/export regulations (e.g., FDA, EAR, ITAR).

• Proficiency in product classification, customs documentation, and regulatory compliance.

• Project Management skills.

• Excellent communication, analytical, and problem-solving skills.

• Presentation and Communication skills.

Preferred:

• Experience with trade management software and ERP systems.

• Certified Customs Specialist (CCS) or Certified Export Specialist (CES).

Work Environment

The work environment characteristics are representative of an office and up to 75% of time at desk, standing or sitting extended periods of time. Will require domestic and international travel up to 20%. Ability to travel on short notice.

Physical Demands

No strenuous physical activity, though occasional light lifting of files and related materials (up to 10 lbs.) is required.

Salary Transparency

The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $126,000 to $214,000 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate.

Equal Employment Opportunity

QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at recruiting@quidelortho.com

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