Validation and Compliance Expert

3 weeks ago


North Chicago, Illinois, United States KYYBA Full time
About the Role

Kyyba is a global company delivering high-quality resources and top-notch recruiting services. We are seeking a skilled Validation and Compliance Expert to join our team. This role involves ensuring compliance with regulatory standards, including FDA, QSR, MDD, ISO, and 21 CFR Part 11.

Key Responsibilities
  • Compliance: Ensure compliance with regulatory standards, including FDA, QSR, MDD, ISO, and 21 CFR Part 11.
  • Validation: Conduct inspections, verifications, and validations of components or materials used in development processes.
  • Documentation: Review documentation for accuracy, clarity, consistency, completeness, and compliance.
  • Communication: Collaborate with cross-functional teams to ensure effective communication and coordination.
Requirements
  • Bachelor's Degree Required
  • Knowledgeable of FDA, Quality System Regulations (QSR), Medical Device Directive, ISO guidelines, and 21 CFR Part 11
Benefits

We offer a competitive salary range of $65,000 - $90,000 per year, a comprehensive benefits package, and opportunities for career growth and development.



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