Cepheid

Regulatory Affairs Specialist

Cepheid(29 days ago)

Bangalore, Karnataka, IndiaOnsiteFull TimeMedior$87,459 - $117,908 (estimated)Regulatory Affairs
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About this role

The Regulatory Affairs Specialist at Cepheid supports on-market sustainment by maintaining product approvals through preparation of global change notifications and updating technical documentation. The role compiles and supports regulatory submission packages across regions, ensures compliance with local, regional, and global requirements, and contributes to audits, inspections, and post-market activities. This on-site position is part of the Global QRC On-Market Sustainment team based in Bengaluru, India.

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Required Skills

  • Regulatory Documentation
  • Submission Preparation
  • Regulatory Intelligence
  • Change Management
  • Compliance Assessment
  • Technical Writing
  • Postmarket Support
  • Audit Support
  • Training
  • SAP

+3 more

Qualifications

  • Master's Degree
  • Bachelor's Degree
  • Valid Driver's License
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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