An immediate start available ideal for someone who can hit the ground running with experience in quality management within medical devices, digital health technologies, or regulated software environments. You will enjoy building systems and translating regulatory requirements into practical, scalable processes that enable innovation while ensuring compliance.
Intro:
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 wide adopted digital health platform.
Job Purpose:
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 an Assignment until 31.07.2027, with possibility of extension.
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 strategy, planning, and technical teams to explore clinical trial applications.
Desirable criteria
6. Experience of working with med tech and/or digital health.
7. Familiarity with ISO 13485:2016, and ISO/IEC 27001.
8. Experience working with open-source software projects.
9. Experience supporting NHS, academic or clinical research environments.
10. Experience preparing organisations for ISO, GDPR, and information governance certifications.
Quality Management Lead in London employer: KEYSTONE EMPLOYMENT GROUP NO.1 LIMITED
As a Student Experience Officer at King's College London, you will be part of a vibrant academic community dedicated to enhancing student engagement and support. The role offers flexible part-time hours, allowing for a balanced work-life dynamic, while providing opportunities for professional growth within a prestigious institution. With a strong emphasis on collaboration and customer service, you'll contribute to a welcoming environment that prioritises student success and satisfaction.
Contact Details:
KEYSTONE EMPLOYMENT GROUP NO.1 LIMITED Recruitment Team
