Do you thrive in a fast-paced environment where quality and regulatory compliance are key to success? Are you an ISO 13485 expert with a keen eye for risk and continuous improvement? If so, GN Hearing Australia has the perfect opportunity for you!
We’re on the lookout for a Quality Assurance & Regulatory Affairs Associate to support and elevate our ANZ operations. You’ll play a crucial role in ensuring compliance with regulatory standards and GN’s global quality management system – while helping improve lives through advanced hearing solutions.
As our QA/RA Associate, you’ll:
- 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 TGA and other bodies.
- Be a key player in a high-performing, values-led QA/RA team.
We’re 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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