Quality And Regulatory Analyst 2

Dexcom Inc

Australia, Country
Not specified
Iso 9001:2015 qms implementation
Medsafe and tga registration knowledge
Pharmacovigilance and device vigilance management
Dexcom Inc. is seeking a Quality and Regulatory Analyst 2 for its subsidiaries, AMSL and NZMS, in Australia. The role focuses on ensuring compliance with quality management systems and regulatory requirements for medical devices, contributing to the overall mission of improving diabetes care

Job Summary

  • The role involves coordinating tasks related to the Quality Management System to ensure compliance with principal company requirements and regulatory frameworks.
  • Candidates will manage pharmacovigilance and device vigilance activities while reviewing advertising materials for alignment with local codes.
  • The position supports product registrations in Australia and New Zealand and investigates quality issues to implement corrective actions.

Matching Summary

Match Score: 85

Dexcom Inc. is seeking a Quality and Regulatory Analyst 2 for its subsidiaries, AMSL and NZMS, in Australia. The role focuses on ensuring compliance with quality management systems and regulatory requirements for medical devices, contributing to the overall mission of improving diabetes care.

Skills & Requirements

Must-have

  • ISO 9001:2015 QMS implementation
  • Medsafe and TGA registration knowledge
  • Pharmacovigilance and device vigilance management

Nice-to-have

  • Strong analytical thinking skills
  • Excellent written communication abilities
  • Collaborative team environment experience

Key Requirements

  • Bachelor's degree required
  • 2-5 years of related experience
  • Knowledge of Medsafe and TGA processes

Work Rights

Not specified

Tailored Resume

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