Regulatory Labelling Associate

Integer

Label creation and control
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 and initiates/implements Change Control Requests pertaining to labeling updates.
  • Provides a comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits.

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
  • change control requests
  • labeling translations management
  • vendor proof review
  • cross-functional collaboration

Nice-to-have

  • continuous improvement focus
  • respectful interaction
  • open and honest communication
  • customer success focus

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter