Regulatory Labelling Associate

Integer

Fda udi gudid database management
Labeling document control
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.
  • Performs upload and maintain the FDA UDI GUDID database and initiates/implements Change Control Requests pertaining to labeling updates.
  • The company offers a comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits, plus 401(k) with company matching.

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

  • FDA UDI GUDID database management
  • labeling document control
  • labeling translation management
  • vendor proof review
  • change control requests

Nice-to-have

  • continuous improvement focus
  • cross-functional collaboration
  • customer success focus
  • respectful interaction

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