Senior Quality Assurance

2 days ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $90,000 - $120,000
Quality Assurance & Regulatory Affairs Associate

We are seeking a highly skilled professional to support and elevate our ANZ operations in quality assurance and regulatory affairs.

Key Responsibilities:
  • Lead day-to-day quality assurance and regulatory affairs 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 quality assurance and regulatory affairs meetings and interactions with regulatory bodies.

To be successful in this role, you will have a solid understanding of ISO 13485 and quality systems, knowledge of internal auditing, CAPA, and validation processes, and be confident, detail-oriented, and self-motivated. You should have 3+ years' experience in a QA/RA role, ideally in medical devices, and be a natural problem solver who thrives in a process-driven environment.

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