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 review formatting and manage translation activities for global products.
  • 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, and 401(k)

Skills & Requirements

Must-have

  • 3 years GMP and FDA experience
  • Adobe InDesign and Illustrator proficiency
  • FDA UDI GUDID database management
  • EU MDR labeling requirements knowledge
  • Change Control process execution

Nice-to-have

  • Strong attention to detail
  • Cross-functional team collaboration
  • Continuous improvement mindset
  • Microsoft Office expertise
  • Label validation plan support

Key Requirements

  • Minimum 3 years of GMP and FDA experience
  • Knowledge of US FDA UDI and EU MDR requirements
  • Proficiency in label creation software tools

Work Rights

Not specified

Tailored Resume

Cover Letter