Our Story

4DMedical is a cutting-edge medical technology company specializing in advanced diagnostic imaging solutions that revolutionize respiratory healthcare. We are an ASX-listed company with products that are FDA-cleared/TGA-approved.

Utilizing our innovative four-dimensional imaging technology, we provide actionable insights into lung function, enabling early detection and precise treatment of respiratory conditions. Complementing our approach, we also develop sophisticated AI-driven lung imaging analysis to enhance the accuracy and depth of diagnostic information. Together, these technologies deliver a comprehensive suite of tools for personalized respiratory care.

Our team is dedicated to pushing the boundaries of medical science to enhance patient outcomes and drive the future of healthcare. Join us at 4DMedical and be part of a vibrant, forward-thinking company committed to making a significant impact on global health through technological excellence and innovation.

As part of our Regulatory Affairs Team, you will primarily be responsible for the preparation, execution, submission, and maintenance/tracking of the company’s Regulatory Affairs documentation for projects, as well as assisting with creating and updating other Regulatory, and occasionally Quality documentation. The Senior Regulatory Affairs Associate will be required to engage with a broad range of internal and external stakeholders. This role will actively build your own knowledge and provide advice on medical device topics to their RA/QA and 4DMedical colleagues for on pre-market and post-market medical device requirements applicable primarily to Australia, but as required, also international standards and/or Quality Processes.

This is an exciting opportunity for ongoing career progression and ​a chance to do regulatory work on cutting edge Software as a Medical Device (SaMD) and Artificial Intelligence.

Responsibilities

• Support the conduct of pre-market activities, such as the preparation, coordination, & submission of technical documentation to health authorities. This includes response preparation to health authority inquiries, working with teams to ensure product claims are consistent with technical documentation, file maintenance including tracking databases appropriate to function, & other activities.
• Support the conduct of post-market surveillance activities, such as the processing of complaint handling, adverse event assessment, reporting & trending, field actions, & other activities.
• Keep a general awareness of regulatory industry changes & support the implementation of identified opportunities for improvement to 4DMedical’s documentation/processes.
• Evaluate product labelling, marketing materials, and ensure product claims are accurate and comply with regulatory requirements and assist Quality team where required.

Experience and Qualifications

• Demonstrated experience working in a regulated environment, at least 5 - 7 years in a regulatory capacity related to medical devices (e.g. Class I-II experience).
• Working experience in registering medical devices with local &/or foreign regulatory authorities/agencies is preferred. Experience in preparing regulatory submissions for Australia is ideal.
• A working knowledge of ISO 13485, ISO 14971 or other quality standards related to the essential principles/requirements, as they relate to regulatory compliance is ideal.
• Understanding and experience in working with ISO 14971 is preferred.
• Ability to work with complex technical documentation, write effective processes, & competently utilise work applications. (e.g. MS Word, MS Excel, etc)

Qualifications

• Tertiary qualified, preferably in a science-related discipline (e.g. sciences, engineering, etc), knowledge of medical device imaging or software as a medical device (SaMD) is ideal.

What can we offer you?

Hybrid working - 2 days from home – 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.

Bonus annual leave scheme as well as company paid Parental leave.

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

How to Apply

Please apply via this link https://4dmedical.bamboohr.com/careers/100?source=aWQ9MjI%3D and submit a current CV and a cover letter that 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: www.4dmedical.com

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