Manager, Export Compliance & ITAR Programs

Job Title: Manager, Export Compliance & ITAR Programs 
Department: Quality  

Reports To: COO 

Location: On-site (4 Sunshine Blvd, Ormond Beach, FL 32174) 
U.S. Person  (ITAR compliance) 

Position Summary 

The Manager, Export Compliance & ITAR Programs leads and maintains the company’s export compliance program in alignment with ITAR, EAR, OFAC, and other U.S. export regulations within a regulated medical device equipment environment (FDA / ISO 13485 / GMP). 

This role ensures compliant handling of export-controlled capital equipment, components, software, and technical data- particularly where medical manufacturing systems intersect with defense, government, or dual-use applications. The position partners cross-functionally to embed export compliance into product development, documentation control, and global operations. 

Key Responsibilities 

Export Compliance Leadership 

• Own and maintain the ITAR/EAR compliance program, including DDTC registration 

• Develop policies, SOPs, risk assessments, and executive reporting 

• Manage export classifications (USML vs. CCL) and regulatory determinations 

• Prepare and manage ITAR licenses, TAAs, MLAs, and related filings 

• Interface with DDTC, BIS, and other agencies as  

Quality System & Engineering Integration 

• Integrate export controls into ISO 13485 QMS and related systems 

• Ensure proper control of technical data within document control, ERP/MRP, and engineering change processes 

• Support DHF, DMR, validation documentation, and supplier qualification alignment 

• Review and classify equipment, automation systems, embedded software, and technical data 

• Define access controls for U.S. Persons and advise on remote diagnostics and cross-border support 

Global Operations & Supply Chain 

• Review and approve international shipments of equipment, parts, software, and service materials 

• Verify ECCNs and export classifications 

• Support global service, repair, and returns processes 

• Promote compliant supplier engagement 

Training, Audits & Compliance Oversight 

• Develop and deliver export compliance training across departments 

• Lead internal audits and support FDA/ISO/export audit readiness 

• Investigate potential violations, manage voluntary disclosures, and drive CAPA activities 

Qualifications 

Experience 

• 7–12+ years in export compliance within aerospace & defense, medical device equipment, or regulated manufacturing 

• Strong hands-on ITAR experience 

• Experience operating within ISO 13485, GMP, or similar QMS 

• Close collaboration with engineering and product development teams 

Technical Knowledge 

• ITAR (22 CFR 120–130), EAR (15 CFR 730–774), OFAC 

• DDTC registration and licensing processes 

• USML classification and technical data controls 

• Familiarity with FDA/ISO documentation systems preferred 

Education 

• Bachelor’s degree ; advanced degree or certification preferred 

Preferred 

• Experience with automation, custom capital equipment, embedded systems, or software export compliance 

• Experience supporting international service or remote diagnostics 

• Export compliance certifications (ECoP, CES) 

• Voluntary disclosure experience 

Success Metrics  

• Clean export audit posture with zero violations 

• ITAR program fully integrated into QMS 

• Clear, documented product classifications 

• Organization-wide export awareness 

• Efficient licensing and shipment processes 

Why This Role Is Critical 

This company operates at the intersection of: 

• Regulated medical manufacturing 

• Export-controlled defense or dual-use equipment 

• Complex custom engineering 

• International customer base 

Export compliance must function as a business enabler, not a bottleneck, while maintaining zero tolerance for violations. 

We are proud to be an Equal Opportunity Employer committed to fostering a diverse and inclusive workplace. We value and celebrate the unique backgrounds, perspectives, and experiences of all individuals, and we believe that diversity drives innovation and growth. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other legally protected status. 

We also maintain a drug-free workplace. Offers of employment may be contingent upon the successful completion of a drug screening, in accordance with applicable laws and company policies.