SaMD Regulatory & Quality Associate - Hybrid + Wellness

4DMedical Limited; Melbourne; Hybrid; AUD 75,000 - 80,000; Full time

Benefits offered by this job

Hybrid working

Close to public transport

Wellness program

Laptop for remote work

Social events

Job summary

4DMedical Limited, an Australia-based medical technology company, is seeking an Regulatory & Quality Associate to support the QMS and SaMD regulatory activities. This early-career role offers hands‑on experience, mentorship, and structured training within a collaborative environment.

You will assist with regulatory documentation, audits, and cross‑functional workflows, while developing capability through hands‑on experience and teamwork. Hybrid working and a wellness program are provided.

Qualifications

• Technical based higher education, e.g. Degree in Engineering, Science or similar.
• 2 years of work experience in a Medical Devices environment.
• Strong written and verbal communication for clear updates, documentation, and stakeholder coordination.
• Experience with Microsoft tools (Word, Excel, PowerPoint and Teams).

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.

Skills

Communication

Cross-functional collaboration

MS Office proficiency

Education

Engineering or Science degree

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Microsoft Teams

Job description

4DMedical Limited, an Australia-based medical technology company, is seeking an Regulatory & Quality Associate to support the QMS and SaMD regulatory activities. This early-career role offers hands‑on experience, mentorship, and structured training within a collaborative environment.

You will assist with regulatory documentation, audits, and cross‑functional workflows, while developing capability through hands‑on experience and teamwork. Hybrid working and a wellness program are provided.