Clinical Safety Officer

Benefits

Additional Information

Do you want a job with a purpose? And do you want to make healthcare safer, better and more reliable? Join our Team! Join us as Clinical Safety Officer at Dedalus , one of the World's leading healthcare technology companies, in New Zealand (Remote or Hybrid in Auckland) to do the best work of your career and make a profound impact in providing better care for a healthier planet. The role requires a registered clinician from within the Healthcare Region who has experience at senior or management level What you'll achieve As the Clinical Safety Officer , you will be responsible for the maintenance and review of the Hazard Register and the creation of the key clinical safety deliverables. You will also help in advising how to mitigate the clinical risks they identify. This role is part of the global clinical safety team and is also part of the wider Quality Assurance and Regulatory Affairs Team. Clinical safety at Dedalus offers a global clinical consultancy, focused on patient safety, and working as a long-term partner with healthcare delivery organizations to improve their services, reduce insurance costs and reduce the number of serious untoward incidents. You will: Be responsible for embedding end-to-end safety and regulatory requirements, gateways and processes into the Software Development Lifecycle as standard Ensure adherence to the required global regulations and legislation for patient safety and product manufacturing, e.g., EU Medical Device Regulation (EU)745/2017 Assist with registration and certification of Dedalus Medical Device / Software Products to facilitate sales within the global market Ensure provision of a formalized, top down and cost-effective approach to safety across Dedalus globally - based on industry best practice, legislation and standards Perform identification of safety risks and issues at earlier stages in product development, resulting in significantly reduced potential for future safety incidents, fewer project delays and, therefore, reduced costs Work towards reduction in the likelihood of successful litigation, in the undesirable event of patient safety incidents caused by Dedalus offerings, due to rigor applied to development with documentary evidence Apply clinical knowledge and expertise to support the development of business process to ensure clinical focus and regulatory compliance. Review test outputs to ensure that the solution is tested from a clinical perspective (safety and effectiveness) and mitigating factors satisfied. Escalate, where necessary, program or project risks and issues through the appropriate channels. Take the next step towards your dream career At Dedalus Life flows through our software . Every day we do something special by helping caregivers and health professionals deliver better care to their served communities. Take the next step in your career that will make a profound impact. Here's what you'll need to succeed: Essential Requirements Product knowledge in healthcare IT or experience of using healthcare IT systems e.g. hospital information systems or picture archiving and communication systems. Registerable qualification with a professional body or relevant up to date practice within healthcare A registered Pharmacist, or a degree-level qualification (or equivalent experience) in a managerial or healthcare-related discipline Provide clinical consultancy and final approval of the clinical safety case. Perform clinical risk assessment and compile clinical safety cases. Perform Health Hazard Evaluation of Post Market Incidents Ability to perform the necessary clinical safety activities required to meet internal and external safety requirements for a specific product and release. Ability to analyze, understand, and interpret regulations and standards for a more general business audience Ability to handle varying activities on multiple products and tasks and switch between them quickly to meet prioritized tasks whilst not losing sight of all other task priorities Broad understanding of Healthcare IT related processes and workflows within the clinical environment and the ability to explain the intended use, function and structure of healthcare IT Products to non-clinical people. Provide guidance and support for non-clinical people to be able to understand the clinical hazards and impact assessments Communicate with regulatory agencies and notified bodies about registration. certifications, incidents and reportable corrections. Desirable Requirements Experience in Risk Management for Medical Devices or Clinical Product (ISO 14971, DCB-0129) Experience of working in a regulated environment Experience with relevant Standards ((EU) MDR/ (EU) IVDR, ISO 13485, IEC 62366, IEC 62304, ISO 9001, ISO 27001) Excellent interpersonal, team worker and personal computer skills. Independent self-starter able to work from home with minimal face to face contact Good analytical and problem-solving skills Ability to deal with and manage change