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 according to established procedures throughout the product life-cycle

Job Summary

  • The role involves preparing, creating, and controlling labels and Instructions for Use according to established procedures throughout the product life-cycle.
  • Candidates must ensure labeling is compliant with FDA regulations, company policies, and other regulatory requirements while managing translation activities.
  • The company offers a comprehensive benefits package including medical, dental, vision, 401(k) matching, and paid time off.

Matching Summary

The role involves preparing, creating, and controlling labels and Instructions for Use according to established procedures throughout the product life-cycle.

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 experience

Key Requirements

  • Minimum 3 years of GMP experience
  • General understanding of FDA UDI requirements
  • Knowledge of EU MDR labeling requirements

Work Rights

Not specified

Tailored Resume

Cover Letter