Regulatory Labelling Associate

H1BConnect

Palm Harbor, FL, United States
Labeling document creation and control
Revision control using process tools
Labeling translation management
Prepares, creates, and controls labels and Instructions for Use according to procedure, including updates throughout the product life-cycle

Job Summary

  • Prepares, creates, and controls labels and Instructions for Use according to procedure, including updates throughout the product life-cycle.
  • Collaborates with cross-functional teams to review product specifications, evaluating product characteristics, special-handling and safety requirements, and type of materials required for labeling development.
  • The total rewards program includes base wages, a cash-based incentive program, overtime pay, shift differentials, and a comprehensive benefits package with immediate eligibility.

Matching Summary

Prepares, creates, and controls labels and Instructions for Use according to procedure, including updates throughout the product life-cycle.

Skills & Requirements

Must-have

  • Labeling document creation and control
  • Revision control using process tools
  • Labeling translation management
  • FDA UDI GUDID database management
  • Change Control Requests for labeling
  • Cross-functional team collaboration

Nice-to-have

  • Continuous improvement in deliverables
  • Technical support for label printing
  • Company values alignment

Key Requirements

  • 3 years of experience in GMP, FDA, Change Control
  • Understanding of U.S. FDA UDI and EU MDR labeling
  • Proficiency with Adobe InDesign and Illustrator
  • Experience with Microsoft Office Suite

Work Rights

Not specified

Tailored Resume

Cover Letter