Cepheid

Analyst I Regulatory Affairs

Cepheid(5 days ago)

West Sacramento, CAOnsiteFull TimeJunior$100,000 - $120,000Regulatory Affairs
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About this role

Beckman Coulter Diagnostics is seeking a Regulatory Analyst I to support regulatory strategies for microbiology-based IVD products, ensuring compliance with FDA and EU IVDR requirements. The role involves assisting with regulatory submissions, supporting cross-functional teams, and applying regulatory standards. The company emphasizes innovation, impact, and providing comprehensive benefits.

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Required Skills

  • Regulatory Submissions
  • FDA Regulations
  • IVDR
  • ISO Standards
  • Medical Devices
  • Microbiology
  • Technical Documentation
  • Regulatory Strategy
  • Communication
  • Detail Oriented
Cepheid

About Cepheid

cepheid.com

Cepheid is delivering a better way to improve patient outcomes by enabling access to molecular diagnostic testing everywhere.

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