Regulatory Labelling Associate

Integer

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 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 ensure labeling is compliant with regulatory, customer, and specification requirements while supporting new product development projects.
  • 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 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

  • 3+ years GMP and FDA experience
  • Proficiency with Adobe InDesign and Illustrator
  • Knowledge of U.S. FDA UDI and EU MDR requirements

Nice-to-have

  • Strong attention to detail and organizational skills
  • Experience with Change Control processes
  • Ability to collaborate with cross-functional teams

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter