The Royal Marsden NHS Foundation Trust
Quality Assurance Manager (Software as a Medical Device)
Location: The Royal Marsden NHS Foundation Trust (Chelsea, London and Sutton, Surrey; Medical Daycare Unit in Kingston Hospital)
Overview
The Royal Marsden and the Institute of Cancer Research Joint Research Strategy, and the RM/ICR NIHR Biomedical Research Centre strategy, both include the development of artificial intelligence (AI) technologies. AI, and computational tools more broadly, are set to become increasingly integral to healthcare and clinical research. Such tools have the potential to enhance decision‑making, improve patient outcomes, and optimise operational efficiency. However, in supporting successful development and deployment, it is essential that we build a robust, scalable, and compliant infrastructure to support these initiatives.
Role Purpose
The Quality Assurance Manager (Software as a Medical Device) will provide expert guidance and support for the development and maintenance of a supportive Quality Management System (QMS) tailored to the needs of clinical research teams within The Royal Marsden NHS Foundation Trust.
Key Responsibilities
* Enable research groups to comply with relevant safety and regulatory standards, such as UK Medical Device Regulations (UK MRD), ISO13485, ISO 14971, and IEC 62304.
* Develop central resources, including Standard Operational Procedures (SOPs), templates, guidance, and expert advice.
* Collaborate with internal teams to foster a standardised, practical approach to SaMD quality management and risk mitigation through the development of a proportionate QMS.
* Provide guidance and support on the development and maintenance of a QMS tailored to clinical research teams.
* When needed and where capacity allows, support with similar tasks on other programmes of strategic importance.
Qualifications
* Significant experience in quality management or regulatory affairs related to medical devices, with a focus on SaMD.
* Holding a postgraduate degree in Software Engineering, Computer Science, or a related field.
* Demonstrated knowledge of UK MRD, ISO13485, ISO 14971, and IEC 62304.
* Strong communication and stakeholder engagement skills.
About the Trust
The Royal Marsden NHS Foundation Trust is a world‑leading cancer centre. We employ over 4,500 staff in a diverse range of careers including nursing, medical, science, radiography, pharmacy, occupational therapy, finance and administrative services. We have two hospitals – one in Chelsea, London, and one in Sutton, Surrey – as well as a Medical Daycare Unit in Kingston Hospital.
At The Royal Marsden, we deal with cancer every day, so we understand how valuable life is. When people entrust their lives to us, they have the right to demand the very best. That's why the pursuit of excellence lies at the heart of everything we do.
At the heart of the hospital is our dedicated team. We offer a stimulating and dynamic working environment, a wide range of staff benefits, learning and development opportunities and clear career pathways. There are opportunities to work flexibly across a range of areas and specialities and we welcome flexible working requests from point of hire to support employees work life balance. We are looking for employees who aspire to excellence, share our values and can play a crucial role in our on‑going achievements.
Contact
For further details / informal visits contact:
Name: Mark Brandon-Grove
Job title: Deputy Director, Research Operations
Email address: mark.brandon-grove@rmh.nhs.uk
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