Regulatory Labelling Associate

599

Base wages; cash-based incentive program; comprehe...
3 years gmp and fda experience
Proficiency with adobe indesign
Knowledge of udi gudid database
The role involves preparing, creating, and controlling labels and Instructions for Use throughout the product life-cycle while adhering to FDA regulations

Job Summary

  • The role involves 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 a general understanding of U.S. FDA UDI and EU MDR labeling requirements.
  • The company offers a comprehensive benefits package including immediate eligibility for medical, dental, vision, and a 401(k) plan with matching contributions.

Matching Summary

The role involves 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, 401(k) match

Skills & Requirements

Must-have

  • 3 years GMP and FDA experience
  • Proficiency with Adobe InDesign
  • Knowledge of UDI GUDID database
  • Experience with Change Control processes
  • Understanding of EU MDR labeling requirements

Nice-to-have

  • Strong attention to detail
  • Cross-functional collaboration skills
  • Continuous improvement mindset
  • Adobe Illustrator proficiency
  • Label creation software knowledge

Key Requirements

  • Minimum 3 years of GMP and FDA experience
  • General understanding of U.S. FDA UDI and EU MDR
  • Proficiency with Microsoft Office and Adobe tools

Work Rights

Not specified

Tailored Resume

Cover Letter