Regulatory Labelling Associate

Integer

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 the updates to these documents throughout the product life-cycle

Job Summary

  • Prepares, creates, and controls labels and Instructions for Use according to procedure, including the updates to these documents throughout the product life-cycle.
  • Perform upload and maintain the FDA UDI GUDID database and initiate and/or implement Change Control Requests pertaining to labeling updates.
  • Our total rewards program is designed to attract, retain, and motivate associates to contribute to Integer’s success, including a comprehensive benefits package with immediate eligibility.

Matching Summary

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

Skills & Requirements

Must-have

  • labeling and Instructions for Use
  • FDA UDI GUDID database
  • Change Control Requests
  • labeling translations
  • vendor proof review
  • label creation software

Nice-to-have

  • common set of values
  • customer success focus
  • continuous improvement
  • cross-functional collaboration

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter