Regulatory Labelling Associate

Integer

Label creation software
Fda udi gudid database
Labeling translations management
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.
  • Collaborates with cross-functional teams to review product specifications, evaluate product characteristics, and ensure labeling is compliant with regulatory requirements.
  • The total rewards program includes base wages, a cash-based 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
  • FDA UDI GUDID database
  • labeling translations management
  • revision control tools
  • Adobe Illustrator
  • Adobe InDesign

Nice-to-have

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

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter