Regulatory Labelling Associate

900

Base wages; cash-based incentive program; comprehe...
3 years gmp experience
Fda udi and eu mdr knowledge
Adobe indesign proficiency
The role involves preparing, creating, and controlling labels and Instructions for Use throughout the product life-cycle while ensuring strict 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 strict adherence to FDA regulations.
  • Candidates must possess strong proficiency with Adobe InDesign and Illustrator to review formatting, graphics, and technical construction of labeling documents.
  • The position offers a comprehensive benefits package including immediate eligibility for medical, dental, vision, disability, life insurance, 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 strict adherence to FDA regulations.

Salary

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

Skills & Requirements

Must-have

  • 3 years GMP experience
  • FDA UDI and EU MDR knowledge
  • Adobe InDesign proficiency
  • Adobe Illustrator proficiency
  • Change Control process experience

Nice-to-have

  • Strong attention to detail
  • Cross-functional collaboration skills
  • Continuous improvement mindset
  • Microsoft Office expertise
  • Label validation support

Key Requirements

  • Minimum 3 years of GMP experience
  • General understanding of US FDA UDI requirements
  • Knowledge of EU MDR labeling requirements
  • Proficiency with label creation software

Work Rights

Not specified

Tailored Resume

Cover Letter