Regulatory Labelling Associate

Integer

Label creation software
Adobe indesign proficiency
Adobe illustrator proficiency
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, initiates and/or implements Change Control Requests pertaining to labeling updates.
  • 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 software
  • Adobe InDesign proficiency
  • Adobe Illustrator proficiency
  • FDA UDI GUDID database management
  • change control process
  • labeling document control

Nice-to-have

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

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter