Manager, Export Compliance & ITAR Programs

GermfreeOrmond Beach, FL
2dOnsite

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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