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.
  • Uploads and maintains the FDA UDI GUDID database and initiates/implements Change Control Requests pertaining to labeling updates.
  • The 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
  • Adobe InDesign proficiency

Nice-to-have

  • Continuous improvement mindset
  • Cross-functional collaboration
  • Technical support for printing

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter