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, creating, and controlling labels and Instructions for Use throughout the product life-cycle while adhering to FDA regulations

Job Summary

  • The role requires preparing, creating, and controlling labels and Instructions for Use throughout the product life-cycle while adhering to FDA regulations.
  • Candidates must possess a minimum of three years of experience in GMP, FDA regulations, and Change Control processes.
  • The company offers a comprehensive benefits package including immediate eligibility for medical, dental, vision, and a 401(k) plan with matching contributions.

Matching Summary

The role requires preparing, creating, and controlling labels and Instructions for Use throughout the product life-cycle while adhering to FDA regulations.

Salary

Base wages; Cash-based incentive program; Comprehensive benefits including medical, dental, vision, 401(k)

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

Key Requirements

  • Minimum 3 years GMP/FDA experience
  • Proficiency in Adobe InDesign
  • Understanding of FDA UDI and EU MDR

Work Rights

Not specified

Tailored Resume

Cover Letter