Quality Assurance Manager (Software as a Medical Device)
Job summary
THE ROYAL MARSDEN NHS FOUNDATION TRUSTQuality Assurance Manager (Software as Medical Device)
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 (Software as 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.
The successful candidate will have significant experience in quality management or regulatory affairs related to medical devices, with a focus on SaMD, and hold a Postgraduate degree in Software Engineering, Computer Science, or related field.
Main duties of the job
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. This role will focus on enabling research groups to comply with relevant safety and regulatory standards, such as of UK Medical Device Regulations (UK MRD), ISO13485, 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 postholder may be assigned to support with similar tasks on other programmes of strategic importance.
About us
The Royal Marsden NHS Foundation Trust is a world-leading cancer centre. Our role is to offer our patients the best cancer care available anywhere in the world, and to continue to make a global contribution to finding better ways of diagnosing and treating cancer. 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.
Job description
Job responsibilities
For further information on this role, please see the attached detailed Job Description and Person Specification:
- Develop and maintain a centralised, proportionate QMS resource, including SOPs, templates, guidance documents, and tools to facilitate researchers independent management of SaMD quality.
- Assist clinical research teams and regulatory compliance functions to ensure appropriate application of quality standards in in interventional research involving SaMD (i.e. Medicines and Healthcare products Regulatory Agency (MHRA) regulated clinical investigations).
- Advise and support clinical research teams on SaMD quality management, ensuring understanding of safety priorities and compliance with applicable standards.
- Support research teams in aligning with or integrating industry partner QMS frameworks where appropriate.
- Collaborate closely with multidisciplinary teams to standardise approaches for SaMD development, risk management, and quality assurance.
- Provide expert input on risk management aligned with ISO 14971, supporting teams in risk identification and mitigation strategies.
- Support preparation for regulatory inspections and audits by advising teams on documentation and inspection readiness.
Person Specification
Education / Qualifications & Experience
- Postgraduate degree in Software Engineering, Computer Science, or related field.
- Practical experience working in software development teams, such as Software Engineer, Tester, Architect, DevOps, or Technical Lead.
- Strong understanding of: oSoftware development lifecycles (waterfall and agile). oRequirements management and traceability. oSoftware verification and validation. oConfiguration management and version control (e.g. Git).
- Significant experience in quality management or regulatory affairs related to medical devices, with a focus on SaMD.
- Proven experience in developing or supporting QMS systems tailored to in-house product deployment (not necessarily large-scale or consultancy-led systems).
- Excellent communication, facilitation and stakeholder engagement skills.
- Demonstrated ability to work with diverse internal teams to standardise quality approaches and provide practical advice on safety and compliance.
- Applied knowledge of UK Medical Device Regulations (UK MDR) and international standards including ISO 13485, ISO 14971 and IEC 62304.
- Experience advising on risk management and quality assurance in software medical devices.
- Experience of deploying Project Management Techniques.
- Professional project management qualification, e.g. Agile, PRINCE2 foundation or equivalent.
- Applicants from academic or university research backgrounds with relevant experience are encouraged to apply.
- Familiarity with proportional QMS implementation in research or academic environments.
- Experience in supporting clinical investigations of SaMD.
- Knowledge of agile or regulated software development environments.
- Professional certifications such as RAPS RAC, ASQ CQE.
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Employer details
Employer name
The Royal Marsden NHS Foundation Trust
Address
Royal Marsden Hospital Sutton
Sutton
SM2 5PT
Employer's website
https://www.royalmarsden.nhs.uk/working-royal-marsden