Regulatory Labelling Associate

Integer

Palm Harbor, FL, United States
Labeling document control
Fda udi gudid database
Change control requests
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

  • labeling document control
  • FDA UDI GUDID database
  • change control requests
  • label validation plans
  • labeling translations management
  • Adobe InDesign proficiency

Nice-to-have

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

Key Requirements

  • 3 years of GMP, FDA, Change Control process
  • General understanding of U.S. FDA UDI and EU MDR labeling
  • Must have US work authorization

Work Rights

Not specified

Tailored Resume

Cover Letter