Regulatory Labelling Associate

Integer

Base wages; cash-based incentive program; comprehe...
Not specified
3+ years gmp and fda experience
Proficiency with adobe indesign and illustrator
Knowledge of u.s. fda udi and eu mdr requirements
Integer is seeking a Regulatory Labelling Associate to manage labeling documentation in compliance with FDA and other regulatory requirements. The role emphasizes attention to detail, collaboration with cross-functional teams, and a commitment to continuous improvement

Job Summary

  • The role involves preparing, creating, and controlling labels and Instructions for Use throughout the product life-cycle while ensuring compliance with FDA regulations.
  • Employees will collaborate with cross-functional teams to support new product development and ensure labeling deliverables meet regulatory and customer specifications.
  • The company offers a comprehensive benefits package including medical, dental, vision, 401(k) matching, and 80 hours of designated holidays per year.

Matching Summary

Match Score: 85

Integer is seeking a Regulatory Labelling Associate to manage labeling documentation in compliance with FDA and other regulatory requirements. The role emphasizes attention to detail, collaboration with cross-functional teams, and a commitment to continuous improvement.

Salary

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

Skills & Requirements

Must-have

  • 3+ years GMP and FDA experience
  • Proficiency with Adobe InDesign and Illustrator
  • Knowledge of U.S. FDA UDI and EU MDR requirements
  • Experience with Change Control processes
  • Ability to manage labeling translations

Nice-to-have

  • Strong attention to detail
  • Cross-functional collaboration skills
  • Continuous improvement mindset
  • Microsoft Office proficiency
  • Excellent organizational abilities

Key Requirements

  • Minimum 3 years of GMP and FDA experience
  • General understanding of U.S. FDA UDI and EU MDR labeling requirements
  • Proficiency in label creation software and Adobe tools

Work Rights

Not specified

Tailored Resume

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