Regulatory Affairs Specialist

3 days ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $120,000 - $130,000
Quality Assurance and Regulatory Affairs Expert

We're seeking a highly skilled Quality Assurance and Regulatory Affairs expert to join our team.

As a key member of our QA/RA function, you'll play a crucial role in ensuring compliance with regulatory standards and internal quality management systems.

  • Lead day-to-day QA and RA activities for Australia, New Zealand, and affiliates.
  • Support compliance with ISO 13485 and local regulatory requirements.
  • Act as the 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 relevant authorities.

The ideal candidate will have:

  • A solid understanding of ISO 13485 and quality systems.
  • Experience in internal auditing, CAPA, and validation processes.
  • Confidence, attention to detail, and self-motivation.
  • Effective communication skills for stakeholder engagement.
  • At least 3 years' experience in a QA/RA role, preferably in medical devices.
  • Natural problem-solving skills and a process-driven approach.
Job Type

Full-time

Seniority Level

Not Applicable

Industry

Medical Equipment Manufacturing, Appliances, Electrical, and Electronics Manufacturing

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