Cepheid

Regulatory Affairs Specialist - 18 months FTC

Cepheid(1 month ago)

O'Callaghan Mills, IrelandOnsiteFull TimeMedior$78,636 - $106,118 (estimated)Quality and Regulatory Affairs
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About this role

A Regulatory Affairs Specialist at Beckman Coulter Diagnostics supporting the Quality and Regulatory Affairs team for the AU Chemistry product line. The role is based onsite at the Co. Clare, Ireland site and is an 18-month contract reporting to the Regulatory Affairs Manager. It operates within the diagnostics/medical devices organization and interfaces with local and global regulatory teams.

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Required Skills

  • CAPA Management
  • Procedure Review
  • Product Registration
  • IVDR Maintenance
  • Design Change
  • Regulatory Submissions
  • Change Management
  • Technical Files
  • Quality Systems
  • Communication Skills

Qualifications

  • B.Sc. in Science
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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