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.
  • The company offers a comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits, plus a 401(k) plan 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
  • Adobe InDesign proficiency
  • Adobe Illustrator proficiency

Nice-to-have

  • Continuous improvement focus
  • Cross-functional collaboration
  • Strong organizational skills
  • Time management abilities

Key Requirements

  • 3 years of GMP, FDA, Change Control process
  • Understanding of U.S. FDA UDI and EU MDR labeling
  • Experience with Microsoft Office

Work Rights

Not specified

Tailored Resume

Cover Letter