Regulatory Labelling Associate

Integer

Base wages; cash-based incentive program; comprehe...
3 years gmp fda experience
Adobe indesign proficiency
Fda udi gudid database knowledge
The role requires preparing, creating, and controlling labels and Instructions for Use according to established procedures throughout the product life-cycle

Job Summary

  • The role requires preparing, creating, and controlling labels and Instructions for Use according to established procedures throughout the product life-cycle.
  • 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, disability, life insurance, and a 401(k) plan with matching contributions.

Matching Summary

The role requires 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 FDA experience
  • Adobe InDesign proficiency
  • FDA UDI GUDID database knowledge
  • Change Control process execution
  • 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/FDA experience
  • Proficiency in Adobe InDesign and Illustrator
  • Knowledge of US FDA UDI and EU MDR

Work Rights

Not specified

Tailored Resume

Cover Letter