QA/Ra Role

4 days ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $60,000 - $100,000

Job Opportunity: Quality Assurance and Regulatory Affairs Associate

We are seeking a highly skilled Quality Assurance and Regulatory Affairs Associate to join our team. As a key member of our quality assurance function, you will play a crucial role in ensuring compliance with regulatory standards and our global quality management system.

The successful candidate will have a solid understanding of ISO 13485 and quality systems, as well as experience in internal auditing, CAPA, and validation processes. They will be confident, detail-oriented, and self-motivated, with excellent communication skills and the ability to work effectively with stakeholders at all levels.

In this role, you will lead day-to-day QA and RA functions for Australia, New Zealand, and affiliates, supporting compliance with ISO13485 and local regulatory standards. You will also act as the local Subject Matter Expert for quality processes and risk assessments, conduct internal audits and manage CAPAs, NCs, and quality records.

Your responsibilities will include driving validation activities for custom-manufactured products at our Sydney facility, collaborating with internal teams and corporate stakeholders across the globe, and training and supporting teams on quality and regulatory matters. You will also represent the business in local QA/RA meetings and interactions with regulatory bodies.

We are looking for someone who is a natural problem-solver and thrives in a process-driven environment. If you have 3+ years' experience in a QA/RA role, ideally in medical devices, and are passionate about quality and regulatory compliance, we encourage you to apply.

Key Responsibilities:

  • Lead day-to-day QA and RA functions for Australia, New Zealand, and affiliates
  • Support compliance with ISO13485 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 regulatory bodies

Required Skills and Qualifications:

  • Solid understanding of ISO 13485 and quality systems
  • Experience in internal auditing, CAPA, and validation processes
  • Confident, detail-oriented, and self-motivated
  • Excellent communication skills and ability to work effectively with stakeholders
  • 3+ years' experience in a QA/RA role, ideally in medical devices

Benefits:

This is an exciting opportunity to join a high-performing, values-led QA/RA team and make a real impact on the success of our organization. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.

About Us:

We are a leading [industry] company with a strong commitment to quality and regulatory compliance. Our team is dedicated to delivering exceptional results and making a positive impact on our customers and the community.

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