POSITION TITLE
QUALITY ASSURANCE MANAGER (SOFTWARE AS A MEDICAL DEVICE)
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.
The Quality Assurance Manager 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. This role will focus on enabling research groups to comply with relevant safety and regulatory standards, such as UK Medical Device Regulations (UK MRD), ISO 13485, ISO 14971, and IEC 62304, by developing central resources, including Standard Operational Procedures (SOPs), templates, guidance and expert advice. The post holder will collaborate with internal teams to foster a standardised, practical approach to SaMD quality management and risk mitigation through the development of a proportionate QMS. Dependent on need and capacity the post holder may be assigned to support similar tasks on other programmes of strategic importance.
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.
The Royal Marsden is a world‑leading cancer centre committed to providing the best care and pioneering cancer research.
RESPONSIBILITIES
* Provide expert guidance and support for the development and maintenance of a QMS tailored to the needs of clinical research teams.
* Enable research groups to comply with safety and regulatory standards (UK MRD, ISO13485, ISO14971, IEC62304) through development of central resources such as SOPs, templates and guidance.
* Collaborate with internal teams to foster a standardised, practical approach to SaMD quality management and risk mitigation.
* Possibly support similar tasks on other strategically important programmes, depending on need and capacity.
QUALIFICATIONS
* Significant experience in quality management or regulatory affairs related to medical devices, with a focus on SaMD.
* Postgraduate degree in Software Engineering, Computer Science, or a related field.
WORKING ENVIRONMENT
* Dynamic, stimulating environment with flexible working arrangements available from day one.
* Opportunities for learning, development and clear career pathways.
* Benefits include a wide range of staff benefits and support for work‑life balance.
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