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, 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, and Change Control processes to ensure regulatory compliance.
  • The company offers a comprehensive benefits package including medical, dental, vision, 401(k) matching, and paid time off.

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 experience
  • FDA UDI and EU MDR knowledge
  • Adobe InDesign proficiency
  • Change Control process expertise
  • Label validation plan execution

Nice-to-have

  • Strong attention to detail
  • Cross-functional collaboration skills
  • Continuous improvement mindset
  • Excellent time management abilities
  • Open communication with customers

Key Requirements

  • Minimum 3 years GMP/FDA experience
  • Knowledge of US FDA UDI requirements
  • Proficiency with Adobe Illustrator
  • Experience with label creation software

Work Rights

Not specified

Tailored Resume

Cover Letter