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 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 a minimum of three years of experience with GMP, FDA regulations, and Change Control processes.
  • The company offers a comprehensive benefits package including immediate eligibility for medical, dental, vision, and a 401(k) plan with matching contributions.

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) match

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
  • Vendor proof approval experience
  • Microsoft Office proficiency

Key Requirements

  • Minimum 3 years GMP experience
  • Knowledge of FDA UDI requirements
  • Proficiency in Adobe Illustrator
  • Understanding of EU MDR labeling

Work Rights

Not specified

Tailored Resume

Cover Letter