Regulatory Labelling Associate

Integer

Fda regulations
Labeling and instructions for use
Revision control
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.
  • Collaborates with cross-functional teams to ensure labeling deliverables are on-track with each project.
  • Provides a comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits.

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

  • FDA regulations
  • labeling and Instructions for Use
  • revision control
  • labeling translations
  • vendor proof review
  • FDA UDI GUDID database
  • Change Control Requests

Nice-to-have

  • continuous improvement
  • cross-functional collaboration
  • technical support for printing
  • common set of values
  • customer success focus

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter