Regulatory Labelling Associate

Integer

Base wages; cash-based incentive program; comprehe...
3 years gmp experience
Fda udi and eu mdr knowledge
Adobe indesign proficiency
The role requires preparing and controlling labels and Instructions for Use throughout the product life-cycle while adhering to FDA regulations

Job Summary

  • The role requires preparing 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 with GMP, FDA regulations, and Change Control processes.
  • The company offers a comprehensive benefits package including medical, dental, vision, and immediate 401(k) matching.

Matching Summary

The role requires preparing 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 experience
  • FDA UDI and EU MDR knowledge
  • Adobe InDesign proficiency
  • Adobe Illustrator proficiency
  • Change Control process execution
  • Label validation plan support

Nice-to-have

  • Strong attention to detail
  • Cross-functional collaboration skills
  • Continuous improvement mindset
  • Microsoft Office expertise
  • Vendor proof review experience

Key Requirements

  • Minimum 3 years GMP experience
  • Knowledge of US FDA UDI requirements
  • Proficiency in Adobe InDesign and Illustrator

Work Rights

Not specified

Tailored Resume

Cover Letter