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.
  • Collaborates with cross-functional teams to ensure labeling deliverables are on-track with each project and evaluates impact assessments related to labeling updates.
  • 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
  • Adobe InDesign proficiency
  • Adobe Illustrator proficiency

Nice-to-have

  • Continuous improvement focus
  • Cross-functional collaboration
  • Strong attention to detail
  • Organizational and time management

Key Requirements

  • 3 years of GMP, FDA, Change Control experience
  • General understanding of U.S. FDA UDI and EU MDR labeling
  • Experience with Microsoft Office
  • Knowledge of label creation software

Work Rights

Not specified

Tailored Resume

Cover Letter