Benefits:
• 12-month contract QA/RA Medical Device role with potential extension.
• Opportunity to join an expanding medical device organization.
• Flexible working arrangements.
• Competitive salary and benefits.


About the company
This organization is pioneering medical technology company at the forefront of life-sustaining therapies, serving patients globally. The team is dedicated to innovating critical care solutions and expanding possibilities in chronic disease management. Be part of a mission to transform patient outcomes through cutting-edge medical devices and digital health technologies.


About the opportunity
As the Quality and Regulatory Associate, you will collaborate closely with the QARA Head-ANZ, and other key stakeholders both locally and internationally. Your responsibilities will include supporting the efficient operation of the Quality Management System, managing product complaints, nonconforming products, and CAPA, and conducting internal audits. To excel in this role, you must have strong leadership skills, comprehensive knowledge of ISO regulations, and excellent planning, influencing, and interpersonal abilities.


Duties
• Support the regional Quality lead in daily QMS operations, including internal audits, quality records control, training and supplier controls, product release and hold, and new product setup, to maintain ISO 9001 certification.
• Drive continuous improvement initiatives to keep the QMS aligned with business growth, regulatory changes, and corporate standards.
• Collaborate with leadership to foster a culture of quality awareness and compliance across the organization.
• Liaise with Operations teams to ensure timely and effective resolution of customer complaints in compliance with regulatory expectations.
• Assist in coordinating post-marketing regulatory activities, including preparing submissions for local health authorities, implementing and reporting field actions, and managing adverse event reporting and product returns.
• Maintain local documentation in line with regional requirements and for international audits, including declarations of conformity, labelling, and electronic submission systems.
• Support activities related to international medical device regulations and unique device identification implementation.
• Actively champion the company's mission, strategies, policies, procedures, and Code of Conduct.

**Please note, the ideal candidate is locally available and has unrestricted working rights in Australia.

Skills and Experience
• Tertiary qualification in a Science, Engineering, or related field.
• Minimum 4 years of QA/RA Medical devices experience.
• Extensive understanding of ISO requirements and recent regulatory changes in the medical device industry.
• Must have experience with Microsoft and TrackWise system.
• Problem solving mindset and strong organizational skills required.


Culture
This organization has a dynamic, supportive culture where positivity and agility thrive. They value quick thinkers who embrace continuous learning and teamwork. Working cohesively to creatively tackle challenges and stay focused on their goals.

How to Apply
Click apply or email Tamara El Husseini, Recruitment Consultant on telhusseini@hpgconnect.com for a confidential discussion.