Regulatory Labelling Associate

Hdkdpunchout

Label creation and control
Revision control and tracking
Fda udi gudid database management
Prepares, creates, and controls labels and Instructions for Use according to procedure, including the updates to these documents throughout the product life-cycle

Job Summary

  • Prepares, creates, and controls labels and Instructions for Use according to procedure, including the updates to these documents throughout the product life-cycle.
  • Perform upload and maintain the FDA UDI GUDID database and initiate and/or implement Change Control Requests pertaining to labeling updates.
  • The company provides a comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits.

Matching Summary

Prepares, creates, and controls labels and Instructions for Use according to procedure, including the updates to these documents throughout the product life-cycle.

Skills & Requirements

Must-have

  • label creation and control
  • revision control and tracking
  • FDA UDI GUDID database management
  • change control requests
  • cross-functional team collaboration
  • label validation support

Nice-to-have

  • continuous improvement focus
  • strong attention to detail
  • organizational and time management

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter