Regulatory Labelling Associate

Integer

Palm Harbor, FL, United States
Label creation software
Fda udi gudid database
Change control process
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.
  • Collaborates with cross-functional teams to review product specifications and ensure labeling is compliant with regulatory, customer, and specification requirements.
  • 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

  • label creation software
  • FDA UDI GUDID database
  • change control process
  • product life-cycle management
  • labeling translations management

Nice-to-have

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

Key Requirements

  • 3 years of experience
  • GMP, FDA knowledge
  • U.S. FDA UDI and EU MDR labeling requirements

Work Rights

Not specified

Tailored Resume

Cover Letter