Regulatory Labelling Associate

809

Palm Harbor, FL, United States
Labeling and instructions for use
Fda udi gudid database
Change control requests
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.
  • Performs upload and maintain the FDA UDI GUDID database, initiates and/or implements Change Control Requests pertaining to labeling updates.
  • 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.

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 and Instructions for Use
  • FDA UDI GUDID database
  • Change Control Requests
  • Adobe InDesign and Illustrator
  • GMP and FDA regulations

Nice-to-have

  • Continuous improvement and consistency
  • Cross-functional team collaboration
  • Customer success focus

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter