Regulatory Labelling Associate

Integer

Base wages; cash-based incentive program; comprehe...
3 years gmp and fda experience
Adobe indesign and illustrator proficiency
Fda udi gudid database management
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 possess strong proficiency with Adobe InDesign and Illustrator to manage technical construction and formatting of labeling documents.
  • The position offers a comprehensive benefits package including immediate eligibility for medical, dental, vision, 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, 401(k) match

Skills & Requirements

Must-have

  • 3 years GMP and FDA experience
  • Adobe InDesign and Illustrator proficiency
  • FDA UDI GUDID database management
  • Change Control process knowledge
  • Label validation plan execution

Nice-to-have

  • EU MDR labeling requirements knowledge
  • Strong attention to detail
  • Cross-functional team collaboration
  • Continuous improvement mindset
  • Vendor proof review skills

Key Requirements

  • Minimum 3 years GMP/FDA experience
  • Knowledge of US FDA UDI and EU MDR
  • Proficiency with label creation software

Work Rights

Not specified

Tailored Resume

Cover Letter