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Job Description
Better & Fairer Care. Always. At St Vincent's, our people are at the heart of everything we do. As Australia's largest not-for-profit health and aged care provider, we are 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. The Opportunity We are seeking an experienced regulatory and business analysis qualified to join St Vincent's Care at Home as a 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 as Software as a Medical Device (SaMD). As Senior Regulatory Business Analyst, you will establish, implement and continuously improve our SaMD 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 act as a 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 requirements and other applicable medical device regulations,



helping embed a sustainable and effective regulatory framework across the organisation.

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 strong knowledge of Software as a Medical Device (SaMD), digital health technologies or other regulated healthcare products. You are confident interpreting complex regulatory requirements and translating them into clear, practical 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 strong analytical capability with sound practical judgement and a commitment to delivering 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 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 Therapeutic Goods Administration submissions and regulatory documentation is desirable A bachelor's degree in Health Sciences, Regulatory Affairs, Biomedical Engineering, Information Technology, Pharmacy, Science, Business Anal

📌 Senior Regulatory Business Analyst (Melbourne)
🏢 Medical Jobs Australia
📍 Melbourne