Regulatory Labelling Associate

442

Base wages; cash-based incentive program; comprehe...
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 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 knowledge of U.S. FDA UDI and EU MDR labeling requirements.
  • The company offers a comprehensive benefits package including medical, dental, vision, 401(k) matching, and 80 hours of designated holidays.

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, and 401(k)

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
  • Cross-functional collaboration skills
  • Continuous improvement mindset
  • Adobe Illustrator proficiency
  • Microsoft Office expertise

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter