Regulatory Affairs & Quality Manager (Medical Devices)
�� Sydney

I’m partnering with a medical device business to appoint a Regulatory Affairs & Quality Manager.

This is a hands-on role suited to someone who enjoys working across both Quality and Regulatory, with a strong focus on maintaining effective systems and ensuring compliance in a practical, real-world environment.

The role: You’ll be responsible for managing Quality and supporting Regulatory activities across the business, with a focus on keeping systems running smoothly and meeting local requirements.

• Maintain and improve the Quality Management System (ISO 13485)
• Support audit activities (internal and external)
• Manage CAPA, document control, and continuous improvement processes
• Assist with product-related quality activities, including investigations where required
• Support regulatory processes, including maintaining product registrations
• Ensure alignment with relevant local regulatory requirements (TGA)
• Develop and maintain SOPs, policies, and procedures
• Work cross-functionally with internal teams

About you: You’ll bring a solid foundation in Quality and/or Regulatory within medical devices, and be comfortable operating in a hands-on role.

• Experience working with ISO 13485 and QMS environments
• Exposure to TGA requirements and product registrations (ARTG)
• Familiar with audits, CAPA, and quality processes
• Able to take a practical, risk-based approach to compliance
• Strong attention to detail and organisational skills
• Comfortable working both independently and with internal stakeholders

Why consider this role:

• Broad exposure across Quality and Regulatory
• Opportunity to contribute to ongoing process improvement
• Collaborative working environment
• Stable role within the medical device sector

Next steps: If this sounds relevant, feel free to apply or reach out for a confidential discussion.