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 required (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 required 

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 required; 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.