Regulatory Labelling Associate

Banknaperville

Label creation and control
Fda udi gudid database
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.
  • Performs upload and maintain the FDA UDI GUDID database and initiates/implements Change Control Requests pertaining to labeling updates.
  • The total rewards program includes base wages, incentive program, comprehensive benefits with immediate eligibility, and 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

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

Nice-to-have

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

Key Requirements

  • 3 years of GMP, FDA, Change Control
  • 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