Job Description: Better & Fairer Care.
At St Vincent's, our people are at the heart of everything we do. This is Australia's largest not‐for‐profit health and aged care provider, committed to delivering exceptional, compassionate care and improving health outcomes for communities across New South Wales, Queensland and Victoria. Guided by our values of Compassion, Justice, Integrity and Excellence, more than 30,000 employees come together each day to make a genuine difference. When you join St Vincent's, you'll become part of a purpose‐driven organisation dedicated to shaping a better and fairer health and aged care system for all.
Opportunity
We are seeking an experienced regulatory and business analysis professional to join St Vincent's Care at Home as Senior Regulatory Business Analyst (SaMD). This is a 12‐month fixed‐term, hybrid opportunity based in Brisbane, Sydney or Melbourne, with a primary focus on enabling the regulation of Medicare Mental Health Check‐In (MMHCI) as Software as a Medical Device.
As Senior Regulatory Business Analyst, you will establish, implement and continuously improve our Software as a Medical Device regulatory capability, ensuring digital health products, clinical software, artificial intelligence solutions and associated operational processes comply with applicable regulatory, quality and risk management requirements. You will be the critical link between regulatory affairs, product development, clinical governance, quality management, technology and operational teams, translating regulatory obligations into practical business processes, governance frameworks, product requirements and organisational controls. You will also support ongoing compliance with Therapeutic Goods Administration (TGA) requirements and other relevant medical device regulations.
What You'll Do
Lead the development and implementation of the organisation's Software as a Medical Device regulatory management framework and governance processes
Interpret and translate medical device regulatory requirements into practical operational, product and technical requirements
Assess software products against applicable regulatory frameworks, support classification activities and identify compliance gaps and remediation actions
Establish and monitor regulatory controls, requirements traceability, documentation and evidence management processes across regulated software products
Support quality management, regulatory risk assessment, audits, inspections, post‐market surveillance and regulatory reporting activities
Work with product, clinical and engineering teams to embed regulatory requirements across design, development, testing, validation,



verification and release processes
Review software changes and emerging digital health initiatives, including artificial intelligence solutions, for regulatory impact
Act as a regulatory business partner by facilitating requirements workshops, advising stakeholders and supporting engagement with regulators, accreditation agencies and external auditors
About You
You are an experienced regulatory professional and business analyst with deep knowledge of Software as a Medical Device, digital health technologies or other regulated healthcare products. You are confident interpreting complex regulatory requirements and turning them into clear, workable processes, controls and product requirements. You build effective relationships across multidisciplinary teams and are comfortable working with clinicians, software developers, product managers, quality specialists and senior stakeholders. You combine solid analytical skills with practical judgement and a commitment to safe, compliant and sustainable digital health services.
Key Experience & Capability
7+ years' experience establishing, implementing or managing regulatory compliance frameworks for Software as a Medical Device (SaMD), digital health technologies or regulated healthcare products
Experience interpreting and applying Therapeutic Goods Administration (TGA) requirements relating to medical devices and software
Experience translating regulatory obligations into business processes, governance controls, system requirements and operational procedures
Demonstrated experience undertaking regulatory gap assessments and implementing corrective actions
Strong business analysis capability, including requirements gathering, process mapping and stakeholder engagement
Experience working with multidisciplinary teams including clinicians, software developers, product managers, quality specialists and executive stakeholders
Experience preparing or supporting TGA submissions and regulatory documentation is desirable
A bachelor's degree in Health Sciences, Regulatory Affairs, Biomedical Engineering, Information Technology, Pharmacy, Science, Business Analysis, Quality Management or a related discipline
Certification in Business Analysis (CBAP or CCBA), or a qualification in Regulatory Affairs, Medical Devices,



Quality Management or Risk Management, is desirable
Formal training in Software as a Medical Device regulation, ISO *****, ISO *****, IEC ***** or related standards is desirable
Why St Vincent's?
Make a meaningful impact - Help establish the regulatory capability supporting a national digital mental health service delivered on behalf of the Commonwealth Government.
Shape safe digital health - Translate regulatory requirements into practical controls that support compliant digital health products, clinical software and emerging technologies.
Work across disciplines - Partner with clinical, product, technology, quality and operational teams throughout the software lifecycle.
Work with purpose - Join a values‐driven organisation guided by Compassion, Justice, Integrity and Excellence.
Enjoy great benefits
Access salary packaging
wellbeing initiatives
employee discounts
a range of additional benefits
Equal Opportunity
At St Vincent's we celebrate diversity and are committed to creating an inclusive workplace where everyone feels valued, respected and empowered to contribute. We welcome applications from people of all backgrounds, including Aboriginal and Torres Strait Islander peoples, people with disability, culturally and linguistically diverse communities, and members of the LGBTQIA+ community.
Closing Date: 20 September *******:59pm
Reconciliation Action Plan
At St Vincent's we acknowledge the importance of creating a work environment that is welcoming, safe, equitable and inclusive for Aboriginal and/or Torres Strait Islander Employees. As part of our Commitment to Reconciliation and Closing the Gap in employment related outcomes, we encourage applications from Aboriginal and Torres Strait Islander Peoples.
St Vincent's Health Australia has been serving Australians with compassionate health and aged care since our first hospital was established in Sydney in ****. Founded by the Sisters of Charity more than 180 years ago, St Vincent's is a clinical, research and education leader delivering private hospital, public hospital and aged care services across NSW, VIC and QLD. Our founder, Mary Aikenhead's vision, commitment and inspiration lives on in us and the work we do. From modest beginnings, St Vincent's Health Australia is today the nation's largest not‐for‐profit health and aged care provider, offering services in Queensland, New South Wales and Victoria, including public and private hospitals and aged care facilities. The St Vincent's family comprises 22,000 outstanding nurses, researchers, cooks, doctors, executives, administrators, cleaners, volunteers and more.
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📌 Senior Regulatory Business Analyst (Melbourne)
🏢 St Vincent's Health Australia
📍 Melbourne