Regulatory Labelling Associate

Ckoi

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.
  • The company 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
  • label validation plans
  • labeling translations management

Nice-to-have

  • continuous improvement focus
  • cross-functional collaboration
  • technical support for printing

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter