Regulatory Labelling Associate

813

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 401(k) with company match.

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 support
  • Adobe InDesign proficiency

Nice-to-have

  • Continuous improvement focus
  • Cross-functional collaboration
  • Customer communication skills

Key Requirements

  • 3 years of GMP, FDA, Change Control
  • US FDA UDI and EU MDR knowledge
  • Must have US work authorization

Work Rights

Must have US work authorization

Tailored Resume

Cover Letter