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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