Regulatory Labelling Associate

Grffeapp

Label creation and control
Fda udi gudid database management
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.
  • Uploads and maintains the FDA UDI GUDID database and initiates/implements Change Control Requests pertaining to labeling updates.
  • Offers a comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits, with 401(k) matching contributions.

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 management
  • change control process
  • label validation support
  • Adobe InDesign proficiency

Nice-to-have

  • continuous improvement focus
  • cross-functional collaboration
  • strong organizational skills
  • attention to detail

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter