At a Glance
- Tasks: Lead the Quality Management System for a cutting-edge digital health platform.
- Company: Join King's College London, a top global research university.
- Benefits: Competitive salary, fixed-term contract, and opportunities for career growth.
- Other info: Collaborative environment with a focus on diversity and inclusion.
- Why this job: Shape quality processes in innovative healthcare technology that impacts lives.
- Qualifications: Experience in quality management within medical devices or regulated software environments.
The predicted salary is between 53947 - 56878 £ per year.
Department: Biostatistics & Health Informatics
About us: King's College London is one of the world's leading research-intensive universities, ranked among the top universities globally and internationally recognised for excellence in education, research, and innovation. With a strong commitment to improving health and society through interdisciplinary collaboration, King's works closely with the NHS, industry, policymakers, and patient communities to translate research into real-world impact.
This role is based within the Department of Biostatistics and Health Informatics, part of the Institute of Psychiatry, Psychology & Neuroscience (IoPPN). The department is recognised for pioneering research in biomedical informatics, digital health, artificial intelligence, and data science, developing innovative methods and technologies that transform healthcare research and clinical practice.
The successful candidate will join the RADAR-base team, a multidisciplinary group developing one of the world's leading open-source platforms for remote patient monitoring using smartphones, wearable devices, and connected technologies. RADAR-base supports large-scale clinical studies and digital health research across multiple disease areas and is used by research institutions worldwide. The platform is currently undergoing significant expansion to support regulated clinical research, Software as a Medical Device (SaMD), and future healthcare applications, making this an exciting opportunity to shape the quality and regulatory foundations of a widely adopted digital health platform.
About the role: We are seeking an experienced and motivated Quality Management Lead to establish, implement, and oversee the Quality Management System (QMS) for the RADAR-base Digital Health Platform. This newly created role will play a central part in preparing the platform for use within regulated clinical research and future Software as a Medical Device (SaMD) applications by embedding quality management principles throughout the platform's development lifecycle.
Working closely with the technical leadership, software engineering teams, product and project managers, researchers, and external regulatory specialists, the candidate will design and implement a QMS aligned with relevant international standards, including ISO 13485 and ISO/IEC 27001, while supporting the platform's longer-term regulatory strategy. The candidate will lead the development of quality processes, document control, change management, risk management and continuous improvement activities, ensuring that quality becomes an integral part of the organisation's culture and development practices.
The role offers a unique opportunity to shape quality and regulatory processes from the ground up within an open-source digital health platform that supports research across mental health, neurological disorders, cardiovascular disease, and other mental and physical conditions.
This position would suit an individual with experience in quality management within medical devices, digital health technologies, or regulated software environments who enjoys building systems, working collaboratively across multidisciplinary teams, and translating regulatory requirements into practical, scalable processes that enable innovation while ensuring compliance.
This is a full-time post (35 hours per week), and you will be offered a fixed term contract until 31.07.2027, with the possibility of extension.
About you: To be successful in this role, we are looking for candidates to have the following skills and experience:
- Essential criteria
- Proven experience implementing or maintaining Quality Management Systems within medical devices, digital health, life sciences or regulated software environments.
- Familiarity with relevant standards, specifically ISO 9001.
- Experience in managing change control processes and supporting regulatory certification preparations and documentation.
- Excellent technical writing and documentation skills, with the ability to create clear tutorials for complex, privacy-oriented deployments.
- Ability to work collaboratively across strategic, technical and operational teams to support clinical research and future regulated applications.
- Desirable criteria
- Experience of more than 3 years' working with MedTech and/or digital health.
- Familiarity with ISO 13485:2016, and ISO/IEC 27001.
- Experience working with open-source software projects.
- Experience supporting NHS, academic or clinical research environments.
- Experience preparing organisations for ISO, GDPR, and information governance certifications.
We ask all candidates to submit a copy of their CV, and a supporting statement, detailing how they meet the essential criteria listed in the person specification section of the job description.
Interviews are due to be held between 26th of August – 2nd of September.
Grade and Salary: £53,947 - £56,878 per annum, including London Weighting Allowance
Quality Management Lead in London employer: King’s College London
King's College London is an exceptional employer, offering a vibrant work culture that prioritises diversity and inclusion. Employees benefit from professional growth opportunities, competitive remuneration, and the chance to contribute to impactful research projects in the heart of Greater London, making it a rewarding environment for those passionate about advancing knowledge and innovation.
