Global Trade Compliance Manager
PROCEPT BioRobotics, San Jose, California, United States, 95199
Embark on an enriching journey with PROCEPT BioRobotics, where our vision, mission, and values guide everything we do as a company. At PROCEPT, we put the patient first in everything we do and are committed to revolutionizing treatment for benign prostatic hyperplasia (BPH, otherwise known as prostate gland enlargement) through innovation in surgical robotics. As our company succeeds and grows, we improve the quality of life of patients, provide more effective treatment options for surgeons, uphold the trust of our shareholders. That starts with a commitment to our People with a focus on creating an evolving landscape for your career, brimming with transformative opportunities that provide continuous career growth opportunities.
Summary The Global Trade Compliance Manager is responsible for designing, implementing, and managing the global trade compliance organization supporting the logistics and supply chain operations of a medical device company. This role ensures full compliance with U.S. and international trade regulations while enabling efficient global distribution in a highly regulated FDA environment. The position serves as the subject matter expert for customs, export controls, sanctions, and global licensing, and partners cross-functionally to mitigate trade risk and support business growth.
Design, establish, and manage the global trade compliance organization, including governance models, policies, and operating procedures.
Develop and maintain global trade compliance policies, SOPs, and internal controls aligned with regulatory requirements and business needs.
Lead trade compliance training programs for entire company.
Import & Customs Compliance
Interpret and apply U.S. Customs and export control regulations, including EAR, ITAR, HTS, and ECCN classifications.
Ensure accurate product classification, valuation, country of origin determination, and documentation and maintaining master data in the QAD system and parts matrix.
Implement and maintain compliance with FDA import regulations for medical technology products.
Oversee customs filings, broker management, and issue resolution to minimize delays and penalties.
Export Controls, Sanctions & Licensing
Establish and manage sanctions and denied party screening programs across global operations.
Serve as an expert resource for global export licensing, including license determination, application, management, and recordkeeping.
Manage deemed export controls and ensure compliance with technology transfer requirements.
Act as primary liaison with U.S. government agencies (e.g., BIS, CBP, FDA) as required.
Conduct trade compliance risk assessments and internal audits; identify gaps and implement corrective actions.
Lead responses to government audits, inquiries, and enforcement actions.
Support potential mergers and acquisitions through trade compliance risk due diligence, integration planning, and remediation activities.
Systems & Data Management
Leverage and maintain global trade management systems to support compliant logistics operations.
Demonstrated working knowledge of systems such as QAD, ACE Portal, E2OPEN, and SNAP-R.
Drive data accuracy, reporting, and continuous improvement through system optimization.
The Qualifications We Need You to Possess:
Bachelor’s degree in supply chain, Logistics, International Trade, Business, or related field experience.
8+ years of progressive experience in global trade compliance within a regulated industry; medical device or life sciences strongly preferred.
Expert-level knowledge of U.S. Customs, BIS regulations, EAR, ITAR, HTS, ECCN, and sanctions compliance.
Proven experience implementing FDA import requirements for medical technology products.
Demonstrated experience designing and managing global trade compliance programs.
Strong stakeholder management and cross-functional leadership skills.
The Qualifications We Would Like You to Possess:
License Customs Broker (LCB) or equivalent trade compliance certification.
Direct experience supporting M&A trade compliance due diligence and post‑merger integration.
Advanced experience with global trade management systems (i.e. ACE, E2OPEN).
Experience working with global logistics networks and international distribution models.
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Summary The Global Trade Compliance Manager is responsible for designing, implementing, and managing the global trade compliance organization supporting the logistics and supply chain operations of a medical device company. This role ensures full compliance with U.S. and international trade regulations while enabling efficient global distribution in a highly regulated FDA environment. The position serves as the subject matter expert for customs, export controls, sanctions, and global licensing, and partners cross-functionally to mitigate trade risk and support business growth.
Design, establish, and manage the global trade compliance organization, including governance models, policies, and operating procedures.
Develop and maintain global trade compliance policies, SOPs, and internal controls aligned with regulatory requirements and business needs.
Lead trade compliance training programs for entire company.
Import & Customs Compliance
Interpret and apply U.S. Customs and export control regulations, including EAR, ITAR, HTS, and ECCN classifications.
Ensure accurate product classification, valuation, country of origin determination, and documentation and maintaining master data in the QAD system and parts matrix.
Implement and maintain compliance with FDA import regulations for medical technology products.
Oversee customs filings, broker management, and issue resolution to minimize delays and penalties.
Export Controls, Sanctions & Licensing
Establish and manage sanctions and denied party screening programs across global operations.
Serve as an expert resource for global export licensing, including license determination, application, management, and recordkeeping.
Manage deemed export controls and ensure compliance with technology transfer requirements.
Act as primary liaison with U.S. government agencies (e.g., BIS, CBP, FDA) as required.
Conduct trade compliance risk assessments and internal audits; identify gaps and implement corrective actions.
Lead responses to government audits, inquiries, and enforcement actions.
Support potential mergers and acquisitions through trade compliance risk due diligence, integration planning, and remediation activities.
Systems & Data Management
Leverage and maintain global trade management systems to support compliant logistics operations.
Demonstrated working knowledge of systems such as QAD, ACE Portal, E2OPEN, and SNAP-R.
Drive data accuracy, reporting, and continuous improvement through system optimization.
The Qualifications We Need You to Possess:
Bachelor’s degree in supply chain, Logistics, International Trade, Business, or related field experience.
8+ years of progressive experience in global trade compliance within a regulated industry; medical device or life sciences strongly preferred.
Expert-level knowledge of U.S. Customs, BIS regulations, EAR, ITAR, HTS, ECCN, and sanctions compliance.
Proven experience implementing FDA import requirements for medical technology products.
Demonstrated experience designing and managing global trade compliance programs.
Strong stakeholder management and cross-functional leadership skills.
The Qualifications We Would Like You to Possess:
License Customs Broker (LCB) or equivalent trade compliance certification.
Direct experience supporting M&A trade compliance due diligence and post‑merger integration.
Advanced experience with global trade management systems (i.e. ACE, E2OPEN).
Experience working with global logistics networks and international distribution models.
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