Regulatory Labelling Associate

Integer

Base wages; cash-based incentive program; comprehe...
3 years gmp and fda experience
Adobe indesign proficiency required
Fda udi gudid database knowledge
The role involves preparing, creating, and controlling labels and Instructions for Use throughout the product life-cycle while adhering to FDA regulations

Job Summary

  • The role involves preparing, creating, and controlling labels and Instructions for Use throughout the product life-cycle while adhering to FDA regulations.
  • Employees must possess strong proficiency with Adobe InDesign and Illustrator to ensure formatting and technical construction conform to established guidelines.
  • The company offers a comprehensive benefits package including medical, dental, vision, 401(k) matching, and 80 hours of designated holidays.

Matching Summary

The role involves 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
  • Adobe InDesign proficiency required
  • FDA UDI GUDID database knowledge
  • Change Control process implementation
  • Label validation plan execution

Nice-to-have

  • Strong attention to detail
  • Cross-functional team collaboration
  • Continuous improvement mindset
  • Vendor proof approval skills
  • Technical support for printing

Key Requirements

  • Minimum 3 years GMP/FDA experience
  • Knowledge of US FDA UDI requirements
  • Understanding of EU MDR labeling standards

Work Rights

Not specified

Tailored Resume

Cover Letter