Regulatory Labelling Associate

Integer

Base wages; cash-based incentive program; comprehe...
3 years gmp and fda experience
Proficiency with adobe indesign
Knowledge of fda udi and eu mdr
The role requires preparing and controlling labels and Instructions for Use while ensuring compliance with FDA regulations and company quality systems

Job Summary

  • The role requires preparing and controlling labels and Instructions for Use while ensuring compliance with FDA regulations and company quality systems.
  • Candidates must perform uploads to the FDA UDI GUDID database and manage translation activities for labeling documents.
  • The position offers a comprehensive benefits package including medical, dental, vision, 401(k) matching, and paid time off.

Matching Summary

The role requires preparing and controlling labels and Instructions for Use while ensuring compliance with FDA regulations and company quality systems.

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 FDA UDI and EU MDR
  • Experience with Change Control processes
  • Strong attention to detail

Nice-to-have

  • Adobe Illustrator proficiency
  • Label creation software knowledge
  • Cross-functional collaboration skills
  • Continuous improvement mindset
  • Microsoft Office experience

Key Requirements

  • Minimum 3 years GMP/FDA experience
  • General understanding of EU MDR requirements
  • Proficiency in regulatory submission support

Work Rights

Not specified

Tailored Resume

Cover Letter