Regulatory Labelling Associate

Integer

Label creation and control
Revision control
Labeling translations
Prepares, creates, and controls labels and Instructions for Use according to procedure, including the updates to these documents throughout the product life-cycle

Job Summary

  • Prepares, creates, and controls labels and Instructions for Use according to procedure, including the updates to these documents throughout the product life-cycle.
  • Collaborate with cross-functional teams to ensure labeling deliverables are on-track with each project.
  • Our total rewards program is designed to attract, retain, and motivate associates to contribute to Integer’s success.

Matching Summary

Prepares, creates, and controls labels and Instructions for Use according to procedure, including the updates to these documents throughout the product life-cycle.

Skills & Requirements

Must-have

  • label creation and control
  • revision control
  • labeling translations
  • vendor proof review
  • FDA UDI GUDID database
  • change control requests
  • cross-functional collaboration

Nice-to-have

  • continuous improvement
  • technical support for printing
  • common set of values
  • unifies and embraces uniqueness

Key Requirements

  • 3 years of GMP, FDA, Change Control experience
  • Understanding of U.S. FDA UDI and EU MDR labeling
  • Proficiency with Adobe InDesign
  • Proficiency with Adobe Illustrator

Work Rights

Not specified

Tailored Resume

Cover Letter