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 fda udi and eu mdr requirements
The role requires preparing and controlling labels and Instructions for Use while ensuring strict adherence to FDA regulations and company quality systems

Job Summary

  • The role requires preparing and controlling labels and Instructions for Use while ensuring strict adherence to FDA regulations and company quality systems.
  • Candidates must perform uploads and maintain the FDA UDI GUDID database while initiating and evaluating Change Control Requests for labeling updates.
  • The position offers a comprehensive benefits package including immediate eligibility for medical, dental, vision, life insurance, and a 401(k) plan with company matching.

Matching Summary

The role requires preparing and controlling labels and Instructions for Use while ensuring strict adherence to FDA regulations and company quality systems.

Salary

Base wages; Cash-based incentive program; Comprehensive benefits including medical, dental, vision, disability, life insurance, adoption benefits, parental leave, and 401(k) matching

Skills & Requirements

Must-have

  • 3 years GMP and FDA experience
  • Proficiency with Adobe InDesign and Illustrator
  • Knowledge of FDA UDI and EU MDR 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
  • Microsoft Office proficiency
  • Excellent organizational abilities

Key Requirements

  • Minimum 3 years of GMP and FDA experience
  • General understanding of US FDA UDI and EU MDR
  • Proficiency in label creation software

Work Rights

Not specified

Tailored Resume

Cover Letter