Regulatory Labelling Associate

81

Palm Harbor, FL, United States
Label creation software
Adobe indesign proficiency
Adobe illustrator proficiency
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.
  • The company offers a comprehensive total rewards program including base wages, incentive programs, and a comprehensive benefits package with immediate eligibility.

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
  • Adobe InDesign proficiency
  • Adobe Illustrator proficiency
  • FDA UDI GUDID database management
  • Change Control Requests

Nice-to-have

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

Key Requirements

  • 3 years of GMP, FDA, Change Control process experience
  • General understanding of U.S. FDA UDI and EU MDR labeling requirements
  • Microsoft Office experience
  • Strong attention to detail
  • Strong organizational and time management abilities

Work Rights

Not specified

Tailored Resume

Cover Letter