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 and initiates/implements Change Control Requests pertaining to labeling updates.
  • Our total rewards program includes base wages, incentive program, comprehensive benefits with immediate eligibility, 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

  • label creation software
  • Adobe InDesign proficiency
  • Adobe Illustrator proficiency
  • labeling document control
  • FDA UDI GUDID database management
  • Change Control Requests

Nice-to-have

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

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter