Regulatory Labelling Associate

Career Pages

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 and consistency
  • cross-functional team collaboration
  • technical support for printing
  • adherence to company values

Key Requirements

  • Minimum 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