Regulatory & Quality Associate

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 is an ASX listed global medical technology company aiming to change the outcomes for patients with lung disease by revolutionising respiratory imaging and ventilation analysis.

Our vision is a world in which people with lung disease have better health outcomes.

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. The Associate will develop capability through hands‑on experience, mentorship, and structured training. The role requires strong organisational skills, attention to detail, a teachable mindset, and the ability to work collaboratively across teams.

Responsibilities/Duties

• 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.

Experience & 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)

What can we offer you?

• Hybrid working – when in the office enjoy our amazing new office space which includes end of trip facilities, and great local coffee and eateries!
• Easy access to Public Transport and very close to Lygon St and the CBD
• Frequent in-house presentations on all aspects of Lung Health & Technology.
• Be a part of our Wellness program including free fruit, table tennis, free gym and corporate class pass, Employee Assistance Program for you and your family, free annual health, free skin check & free flu shot.
• Rewards and Recognition Program including discounts for shopping and goods.
• Laptop and accessories provided for remote work
• Regular social events.
  This is an exceptional opportunity to join a forward-thinking, fast-growing company and make a real difference

4DMedical provides an inclusive work environment and embraces the diverse talent of its people.

For more company information visit our website: www.4dmedical.com

75,000 - 80,000 AUD per year (Carlton (Melbourne Connect))