Regulatory & Quality Associate

Our Story

4DMedical is a global medical technology company aiming to change the outcomes for patients with lung disease by revolutionizing respiratory imaging and ventilation analysis.

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

We are an ASX listed medical technology company and are currently in a high-growth stage of the business.

The Regulatory & Quality Associate supports the effective operation of 4DMedicals 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 handson 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 crossfunctional 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

How to Apply

Please apply via this link submit a current CV and a cover letter which details your alignment with the requirements of the role.

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

For more company information visit our website:

Should you have any queries regarding the position please contact the 4DMedical Recruitment Team at:

Required Experience:

Junior IC