Regulatory Labelling Associate

576

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

Job Summary

  • The role involves preparing, creating, and controlling labels and Instructions for Use throughout the product life-cycle while ensuring adherence 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 immediate eligibility for medical, dental, vision, and a 401(k) plan with company matching.

Matching Summary

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

Salary

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

Skills & Requirements

Must-have

  • 3 years GMP experience
  • FDA UDI database knowledge
  • Adobe InDesign proficiency
  • Change Control process expertise
  • 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 of GMP experience
  • Knowledge of US FDA UDI and EU MDR
  • Proficiency with label creation software

Work Rights

Not specified

Tailored Resume

Cover Letter