Manager, Export Compliance & ITAR Programs
About The Position
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.
Requirements
- 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
- 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
- Bachelor’s degree
Nice To Haves
- advanced degree or certification 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
Responsibilities
- 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
- 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
- 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
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Manager
