Regulatory Labelling Associate

Integer

Base wages; cash-based incentive program; comprehe...
3 years gmp experience
Fda udi database management
Adobe indesign proficiency
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.
  • Candidates 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 experience
  • FDA UDI database management
  • Adobe InDesign proficiency
  • Change Control process knowledge
  • EU MDR labeling requirements

Nice-to-have

  • Strong attention to detail
  • Cross-functional collaboration skills
  • Continuous improvement mindset
  • Vendor proof approval experience

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter