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Regulatory & Quality Associate

4DMedical · Posted Nov 9, 2026

Carlton, Victoria, Australia
Hybrid
Full-time · Associate
2+ years

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The Regulatory & Quality Associate supports the effective operation of 4DMedical’s Quality Management System (QMS) and regulatory compliance activities for Software as a Medical Device (SaMD) products. This role is for an individual in the early stages of their regulatory and quality career.

Responsibilities

Support the owner of the Quality Management System (QMS) with document control, change management, and audit preparation.
Assist with the preparation, organisation, and upkeep of regulatory documentation and submissions across key markets.
Collaborate with cross‑functional teams to ensure regulatory and quality requirements are incorporated into product development and operational workflows.
Provide general support to senior team members as needed, helping manage workload, administrative tasks, and prioritised activities to ensure the smooth functioning of the team.

Requirements

Degree in Engineering
Degree in Science

Skills

Medical Devices experience Strong written and verbal communication Organizational skills Attention to detail

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