Regulatory Labelling Associate

Integer

Label creation and control
Fda udi gudid database
Change control process
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.
  • Perform upload and maintain the FDA UDI GUDID database and initiate and/or implement Change Control Requests pertaining to labeling updates.
  • The company 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

  • label creation and control
  • FDA UDI GUDID database
  • change control process
  • label validation plans
  • Adobe InDesign proficiency

Nice-to-have

  • continuous improvement focus
  • cross-functional collaboration
  • strong organizational skills
  • attention to detail

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter