Regulatory Labelling Associate

anzeigenexpress.de

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.
  • Uploads and maintains the FDA UDI GUDID database, initiates and implements Change Control Requests pertaining to labeling updates.
  • Collaborates with cross-functional teams to review product specifications, evaluate product characteristics, and ensure labeling compliance with regulatory requirements.

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

Nice-to-have

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

Key Requirements

  • Minimum 3 years GMP/FDA experience
  • Experience with Change Control process
  • Understanding of U.S. FDA UDI
  • Understanding of EU MDR labeling

Work Rights

Not specified

Tailored Resume

Cover Letter