Regulatory Labelling Associate

Integer

Base wages; cash-based incentive program; comprehe...
3 years gmp and fda experience
Adobe indesign and illustrator proficiency
Fda udi gudid database management
The role requires preparing, creating, and controlling labels and Instructions for Use throughout the product life-cycle while adhering to FDA regulations

Job Summary

  • The role requires preparing, creating, and controlling labels and Instructions for Use throughout the product life-cycle while adhering to FDA regulations.
  • Candidates must possess strong proficiency with Adobe InDesign and Illustrator to ensure formatting and technical construction conform to established guidelines.
  • The company offers a comprehensive benefits package including immediate eligibility for medical, dental, vision, and a 401(k) plan with company matching.

Matching Summary

The role requires preparing, creating, and controlling labels and Instructions for Use throughout the product life-cycle while adhering to FDA regulations.

Salary

Base wages; Cash-based incentive program; Comprehensive benefits including medical, dental, vision, disability, life insurance, and 401(k) matching

Skills & Requirements

Must-have

  • 3 years GMP and FDA experience
  • Adobe InDesign and Illustrator proficiency
  • FDA UDI GUDID database management
  • Change Control process knowledge
  • Label validation plan execution

Nice-to-have

  • EU MDR labeling requirements knowledge
  • Strong attention to detail
  • Cross-functional team collaboration
  • Continuous improvement mindset
  • Vendor proof approval skills

Key Requirements

  • Minimum 3 years of GMP and FDA experience
  • General understanding of US FDA UDI and EU MDR requirements
  • Proficiency with label creation software

Work Rights

Not specified

Tailored Resume

Cover Letter