Senior Regulatory Affairs Associate
Senior Regulatory Affairs Associate
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Job Description
Our Story
4DMedical is a cuttingedge medical technology company specializing in advanced diagnostic imaging solutions that revolutionize respiratory healthcare. We are an ASXlisted company with products that are FDAcleared/TGAapproved.
Utilizing our innovative fourdimensional 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 AIdriven 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 forwardthinking 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 submission and maintenance/tracking of the companys 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 their own knowledge and provide advice on medical device topics to their RA/QA and 4DMedical colleagues for on premarket and postmarket 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 premarket 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 postmarket surveillance activities such as the processing of complaint handling adverse event assessment reporting & trending field actions & other activities.
Keeps a general awareness of regulatory industry changes & supports the implementation of identified opportunities for improvement to 4DMedicals 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 III 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 sciencerelated 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 officeenjoyour 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 inhouse 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 familyfree annual healthfree 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 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
Should you have any queries regarding the position please contact the 4DMedical Recruitment Team at:
Required Experience:
Senior IC
Employment Type
Full-Time
