Regulatory Labelling Associate

Integer

Labeling document control
Fda udi gudid database management
Change control requests
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 support with internal and external Regulatory submission packages and labeling projects for new product development and current production.

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 management
  • Change Control Requests
  • Adobe InDesign proficiency
  • Adobe Illustrator proficiency

Nice-to-have

  • Continuous improvement focus
  • Cross-functional collaboration
  • Customer communication

Key Requirements

  • 3 years of GMP, FDA, Change Control process experience
  • General understanding of U.S. FDA UDI and EU MDR labeling requirements

Work Rights

Not specified

Tailored Resume

Cover Letter