Regulatory Labelling Associate

Integer

Base wages; cash-based incentive program; comprehe...
Fda udi gudid database management
Adobe indesign and illustrator proficiency
Gmp and fda regulatory knowledge
The role involves preparing, creating, and controlling labels and Instructions for Use according to established procedures throughout the product life-cycle

Job Summary

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

Matching Summary

The role involves preparing, creating, and controlling labels and Instructions for Use according to established procedures throughout the product life-cycle.

Salary

Base wages; Cash-based incentive program; Comprehensive benefits including medical, dental, vision, 401(k) match

Skills & Requirements

Must-have

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

Nice-to-have

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

Key Requirements

  • Minimum 3 years of GMP and FDA experience
  • General understanding of US FDA UDI and EU MDR
  • Experience with Change Control processes

Work Rights

Not specified

Tailored Resume

Cover Letter