Regulatory Labelling Associate

Integer

Label creation and 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.
  • Collaborates with cross-functional teams to ensure labeling deliverables are on-track with each project and provides support for regulatory submission packages.

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 and control
  • FDA UDI GUDID database
  • change control requests
  • label validation plans
  • Adobe InDesign proficiency
  • Adobe Illustrator proficiency

Nice-to-have

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

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter