Regulatory Labelling Associate

163

Base wages; cash-based incentive program; overtime...
3 years gmp and fda experience
Proficiency with adobe indesign
Knowledge of u.s. fda udi requirements
The role involves preparing, creating, and controlling labels and Instructions for Use throughout the product life-cycle

Job Summary

  • The role involves preparing, creating, and controlling labels and Instructions for Use throughout the product life-cycle.
  • Candidates must ensure all labeling documents comply with FDA regulations, company policies, and quality management systems.
  • The position offers a comprehensive benefits package including medical, dental, vision, and immediate 401(k) matching.

Matching Summary

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

Salary

Base wages; cash-based incentive program; overtime pay, shift differentials, and call-in pay when applicable

Skills & Requirements

Must-have

  • 3 years GMP and FDA experience
  • Proficiency with Adobe InDesign
  • Knowledge of U.S. FDA UDI requirements
  • Experience with Change Control processes
  • Ability to manage labeling translations

Nice-to-have

  • Strong attention to detail
  • Excellent organizational skills
  • Collaborative cross-functional teamwork
  • Continuous improvement mindset
  • Adobe Illustrator proficiency

Key Requirements

  • Minimum 3 years of GMP and FDA experience
  • General understanding of EU MDR labeling requirements
  • Proficiency with Microsoft Office and label creation software

Work Rights

Not specified

Tailored Resume

Cover Letter