Regulatory Labelling Associate

Fourstateshomepage

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.
  • 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

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

Nice-to-have

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

Key Requirements

  • Minimum 3 years GMP, FDA, Change Control
  • General understanding of U.S. FDA UDI
  • General understanding of EU MDR labeling
  • Proficiency with Adobe InDesign
  • Proficiency with Adobe Illustrator

Work Rights

Not specified

Tailored Resume

Cover Letter