Regulatory Labelling Associate

Dataroomspot

Label creation software
Adobe indesign proficiency
Adobe illustrator proficiency
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 evaluating product characteristics, special-handling and safety requirements, and type of materials required for labeling development.
  • The total rewards program includes base wages, incentive program, comprehensive benefits with immediate eligibility, and 401(k) plan 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

  • label creation software
  • Adobe InDesign proficiency
  • Adobe Illustrator proficiency
  • FDA UDI GUDID database management
  • Change Control Requests
  • labeling translations management

Nice-to-have

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

Key Requirements

  • 3 years of GMP, FDA, Change Control process
  • U.S. FDA UDI and EU MDR labeling requirements knowledge
  • Microsoft Office experience
  • Strong organizational and time management abilities

Work Rights

Not specified

Tailored Resume

Cover Letter