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 and controlling labels and Instructions for Use throughout the product life-cycle while adhering to FDA regulations

Job Summary

  • The role requires preparing and controlling labels and Instructions for Use throughout the product life-cycle while adhering to FDA regulations.
  • Candidates must possess strong proficiency with Adobe InDesign and Illustrator to ensure formatting and technical construction conform to guidelines.
  • 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 requires preparing 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)

Skills & Requirements

Must-have

  • 3 years GMP FDA experience
  • Adobe InDesign proficiency
  • FDA UDI GUDID database knowledge
  • Change Control process execution
  • Label validation plan support

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
  • Knowledge of EU MDR labeling requirements
  • Proficiency with label creation software

Work Rights

Not specified

Tailored Resume

Cover Letter