Regulatory Labelling Associate

Brianpdon

Labeling document 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 company offers a comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits, plus 401(k) 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

  • labeling document control
  • FDA UDI GUDID database
  • change control process
  • Adobe InDesign proficiency
  • Adobe Illustrator proficiency

Nice-to-have

  • continuous improvement focus
  • cross-functional collaboration
  • strong organizational skills
  • time management abilities

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter