Clinical Safety & Research Lead
- Clinical safety documentation : update and maintain DCB0129/0160 documentation, regularly meet with Clinical Safety Officers from deploying ICBs.
- Evidence and pilots : lead real-world pilots and evidence-framework studies (e.g. NICE ESF) in collaboration with academic and world-class research organisations, validating safety, usability and clinical impact
- Governance support : partner with our governance team to sustain ISO certifications, ISO risk-management docs, manage medical-device registration technical files and QMS processes and oversee CAPA and change-control workflows
- Research leadership : design, run and publish quantitative and qualitative clinical studies on our AI scribe and productivity tool
- Quality assurance : work with Engineering, Product and Design to QA new features, ensuring every release meets clinical safety and regulatory standards
- Strategic advice : brief senior leadership on clinical safety governance, regulatory strategy and research outcomes
- Medical degree (MD, MBBS or equivalent) or other high-level clinical qualification (e.g. Psychology, RN, etc). Preference for clinicians registered in the UK.
- Clinical safety and regulation : NHS Digital Clinical Safety Practitioner course complete and CSO experience (must have); deep knowledge of DCB0129/0160 and navigating the medical device space (ISO standards, MHRA etc)
- Quality systems : built or audited QMS with controlled document, change and CAPA processes and maintained full technical files through development and post-market phases
- Research and validation : proven track record designing, running and publishing clinical studies on health software; hands-on with evidence frameworks (e.g. NICE ESF) and real-world pilots
- AI & health-tech expertise : solid grasp of AI/ML models in healthcare (clinical documentation), their limits and evaluation metrics; hands-on with EHRs, clinical decision-support and standards like FHIR, SNOMED and GDPR
- Academic partnerships : initiated and managed collaborations or sponsored studies with leading research institutions as well as co-authored grants or papers and translated findings into product improvements
- We create unconventional solutions to difficult problems and we build them fast. We want you to set impossible goals and make them happen, think landing a rocket but the medical version.
- You'll be surrounded by a world-class team of engineers, medicos and designers to do your best work, inspired by our shared beliefs:
- We will stop at nothing to improve patient care across the world.
- We design user experiences for joy and ship them fast.
- We make decisions in a flat hierarchy that prioritizes the truth over rank.
- We provide the resources for people to succeed and give them the freedom to do it.
- Flexible hybrid working environment, with 3 days in the office.
- Additional paid day off for your birthday and wellness days
- Special corporate rates at Anytime Fitness in Melbourne, Sydney tbc.
- A generous personal development budget of $500 per annum
- Learn from some of the best engineers and creatives, joining a diverse team
- Become an owner, with shares (equity) in the company, if Heidi wins, we all win
- Rare chance to create a global impact as you immerse yourself in one of Australia's leading healthtech startups
- If you have an impact quickly, the opportunity to fast track your startup career!
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