Regulatory Labelling Associate

Integer

Palm Harbor, FL, United States
Label creation and control
Fda udi gudid database management
Change control process
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.
  • Upload and maintain the FDA UDI GUDID database, initiate and/or implement 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

  • label creation and control
  • FDA UDI GUDID database management
  • change control process
  • labeling translations management
  • vendor proof review

Nice-to-have

  • continuous improvement focus
  • cross-functional team collaboration
  • strong attention to detail
  • organizational and time management

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter