Regulatory Labelling Associate

Coldstonemenu

Label creation and control
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.
  • 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 the updates to these documents throughout the product life-cycle.

Skills & Requirements

Must-have

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

Nice-to-have

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

Key Requirements

  • 3 years of GMP, FDA, Change Control experience
  • Knowledge of U.S. FDA UDI
  • Knowledge of EU MDR labeling requirements

Work Rights

Not specified

Tailored Resume

Cover Letter