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 processesAssist 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.
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