Regulatory Labelling Associate

Integer

Labeling document control
Fda udi gudid database
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 and initiates/implements Change Control Requests pertaining to labeling updates.
  • The total rewards program includes base wages, incentive program, overtime pay, and a comprehensive benefits package with immediate eligibility, including medical, dental, vision, and 401(k) with company 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 Requests
  • Adobe InDesign proficiency
  • Adobe Illustrator proficiency
  • Label creation software knowledge

Nice-to-have

  • Continuous improvement focus
  • Cross-functional collaboration
  • Customer success focus
  • Respectful interaction

Key Requirements

  • Minimum 3 years GMP/FDA experience
  • Change Control process experience
  • U.S. FDA UDI labeling knowledge
  • EU MDR labeling knowledge

Work Rights

Not specified

Tailored Resume

Cover Letter