Permanent full-time position to drive QARA activities for the ANZ markets.
Enjoy excellent work-from-home flexibility!
Are you an experienced hands-on RA / QA professional looking to take the next step in your career? This role is your opportunity to join a company transforming to become a world-class medical device organisation. With exciting projects and a collaborative culture, this role is ideal for someone ready to lead change and drive compliance across ANZ and global markets.
Reporting to the Global RA QA Director, the Global RA / QA Lead will play a key role in ensuring compliance for the ANZ market. Their key responsibilities will include but will not be limited to:
Acting as the primary RA / QA contact for Australia and New Zealand. Ensuring compliance with TGA and EU regulations. Overseeing complaint handling, vigilance reporting, and internal audits. Supporting the development of a global eQMS. Conducting audits and ensuring alignment with ISO 13485. Managing technical documentation and supporting supplier management. Building a strong culture of quality, fostering cross-functional collaboration with Sales, R&D, and Operations. In order to be considered for this role, you will have the below skills and qualifications:
A minimum of 6 years of RA / QA experience in the medical device industry. Strong understanding of TGA and ISO 13485 regulations. Hands-on experience with complaint handling, technical documentation, and internal audits. A proactive, adaptable mindset with excellent communication and problem-solving skills. Strong analytical and problem-solving skills, with the ability to identify and address complex issues. Excellent communication and interpersonal skills. Demonstrated ability to manage projects and meet tight deadlines. This role is a great opportunity to make a global impact by collaborating with teams across ANZ, the US, Europe, and Asia to shape compliance, while leading dynamic projects. For a confidential conversation about this role, please call Grace Bitodi.
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