Quality Assurance Manager (Software as a Medical Device)

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Detailed job description and main 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

Essential criteria

• 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: • Software development lifecycles (waterfall and agile). • Requirements management and traceability. • Software verification and validation. • Configuration 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.

Desirable criteria

• 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.

The Royal Marsden values diversity and is committed to the recruitment and retention of underrepresented minority groups. We particularly welcome applications from Black, Asian and minority ethnic candidates, LGBTQ+ candidates and candidates with disabilities.

As a Disability Confident Employer, we are working to create a workplace that enables all staff to reach their full potential. We are committed to this because we know that greater diversity and inclusion will lead to an even greater positive impact for the people we serve.

Due to the high volumes of applications we receive, we reserve the right to close any adverts before the published closing date once we have received a sufficient number of applications. We advise you to submit your application as early as possible to prevent disappointment. Please ensure your information is accurate to avoid errors with processing your application

All applicants will be contacted by email to the address supplied on your application. Applicants are advised to check their email accounts regularly and to ensure that email filters are set to allow our emails.

Flu Vaccination - What We Expect of our Staff

At The Royal Marsden we have an immune compromised patient population who we must protect as much as we can against the flu virus. Each year, seasonal flu affects thousands of people in the UK. Occurring mainly in winter, it is an infectious respiratory disease capable of producing symptoms ranging from those similar to a common cold, through to very severe or even fatal disease.

The wellbeing of our staff and patients is of the upmost importance to us, and it is the expectation of The Royal Marsden that all patient-facing staff have an annual flu vaccination, provided free of charge by the Trust.

Employer certification / accreditation badges

Documents to download

• 282-CR1206 Job Description and Person Specification (PDF, 440.5KB)
• Job Features Form (PDF, 128.6KB)
• Royal Marsden Trust Values (PDF, 715.5KB)
• Workplace Wellbeing and Rewards Guide (PDF, 1.2MB)