Regulatory Labelling Associate

636

Base wages; cash-based incentive program; comprehe...
3+ years gmp and fda experience
Proficiency with adobe indesign and illustrator
Knowledge of u.s. fda udi and eu mdr 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 in 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 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, disability, life insurance, and 401(k) match

Skills & Requirements

Must-have

  • 3+ years GMP and FDA experience
  • Proficiency with Adobe InDesign and Illustrator
  • Knowledge of U.S. FDA UDI and EU MDR requirements
  • Experience with Change Control processes
  • Ability to perform label validation plans

Nice-to-have

  • Strong attention to detail and organizational skills
  • Collaboration with cross-functional teams
  • Continuous improvement mindset
  • Microsoft Office proficiency

Key Requirements

  • Minimum 3 years of GMP and FDA experience
  • General understanding of U.S. FDA UDI and EU MDR labeling
  • Proficiency with label creation software

Work Rights

Not specified

Tailored Resume

Cover Letter