Expert Healthcare Compliance Specialist

4 days ago


Saint Leonards, Victoria, Australia beBeeQuality Full time $80,000 - $150,000
Job Title: Quality Assurance and Regulatory Associate

A leading global provider of acute critical care solutions seeks an experienced professional to join its Australia and New Zealand team in a specialist, standalone role.

This position involves ensuring compliance with Australian and New Zealand health and safety legislation and quality standards through the development and implementation of local frameworks, audits, and documentation management.

The ideal candidate will have significant experience in WHS and QA functions within the Australian medical device sector, with expertise in quality standards ISO 9001 and ISO 13485.

Key Responsibilities:

  • Ensure compliance with relevant Australian and New Zealand health and safety legislation and quality standards.
  • Develop and implement local QA and WHS frameworks, adapting global policies to local requirements.
  • Conduct internal QA audits and oversee external audit preparedness.
  • Manage and maintain a Quality Management System (QMS) that supports compliance with ISO 9001, ISO 13485, and regulatory expectations specific to the Australian medical device sector.
  • Write, update, and control all QA documentation to ensure it is owned and governed locally.

Requirements:

  • Minimum 3–5 years' experience in a WHS or QA function with Australian legislative experience.
  • Proven understanding of WHS laws in Australia and related frameworks.
  • Familiarity with quality standards including ISO 9001, ISO 13485.
  • Demonstrated experience writing and managing Australian WHS and QA documentation and systems.


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