Quality Assurance and Regulatory Compliance Specialist

2 weeks ago

Sydney, New South Wales, Australia beBeeQuality Full time $100,000 - $140,000

As a Quality Assurance & Regulatory Affairs Associate, you will play a crucial role in ensuring compliance with regulatory standards and our global quality management system. Your expertise in ISO 13485 and risk assessments will be invaluable in improving the lives of individuals through advanced hearing solutions.

Job Description

Our company is seeking an experienced professional to lead day-to-day QA and RA functions for Australia, New Zealand, and affiliates. This key role will support compliance with ISO 13485 and local regulatory standards.

  • Lead QA and RA functions for Australia, New Zealand, and affiliates.
  • Support compliance with ISO 13485 and local regulatory standards.
  • Act as the local Subject Matter Expert for quality processes and risk assessments.
  • Conduct internal audits and manage CAPAs, NCs, and quality records.
  • Drive validation activities for custom-manufactured products at our Sydney facility.
  • Collaborate with internal teams and corporate stakeholders across the globe.
  • Train and support teams on quality and regulatory matters.
  • Represent the business in local QA/RA meetings and interactions with TGA and other bodies.
Requirements

We are looking for someone who:

  • Has a solid understanding of ISO 13485 and quality systems.
  • Knows their way around internal auditing, CAPA, and validation processes.
  • Is confident, detail-oriented, and self-motivated.
  • Communicates effectively with stakeholders at all levels.
  • Has 3+ years' experience in a QA/RA role, ideally in medical devices.
  • Is a natural problem-solver and thrives in a process-driven environment.

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