At a Glance
- Tasks: Lead the development of a Quality Management System for clinical research teams.
- Company: Join a world-leading cancer centre committed to pioneering research and patient care.
- Benefits: Flexible working, career development opportunities, and a supportive work-life balance.
- Other info: Dynamic environment with opportunities for learning and growth from day one.
- Why this job: Make a real impact in healthcare by ensuring compliance and quality in innovative AI technologies.
- Qualifications: Experience in quality management for medical devices and a relevant postgraduate degree.
The predicted salary is between 48000 - 72000 £ per year.
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.
Quality Assurance Manager (Software as a Medical Device) in Sutton Coldfield employer: The Royal Marsden
The Royal Marsden NHS Foundation Trust is an exceptional employer, offering a dynamic and stimulating work environment that prioritises employee growth and development. With flexible working arrangements from day one and a commitment to work-life balance, staff are supported through a comprehensive range of benefits while contributing to pioneering cancer research and innovative healthcare solutions in a world-leading cancer centre located in London and Surrey.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Assurance Manager (Software as a Medical Device) in Sutton Coldfield
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend relevant events, and connect with professionals on LinkedIn. You never know who might have the inside scoop on job openings or can refer you directly.
✨Tip Number 2
Prepare for interviews by researching the company and its projects. Understand their approach to quality management in software as a medical device. This will help you tailor your answers and show that you're genuinely interested in their work.
✨Tip Number 3
Practice common interview questions related to quality assurance and regulatory standards. Be ready to discuss your experience with UK MRD, ISO 13485, and other relevant regulations. Confidence is key!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re serious about joining our team at The Royal Marsden.
We think you need these skills to ace Quality Assurance Manager (Software as a Medical Device) in Sutton Coldfield
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Quality Assurance Manager role. Highlight your experience with quality management systems and regulatory standards like ISO 13485 and UK MRD. We want to see how your background aligns with our needs!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about quality assurance in healthcare and how you can contribute to our mission at The Royal Marsden. Keep it engaging and relevant to the job description.
Showcase Relevant Experience:When detailing your work history, focus on experiences that relate directly to SaMD and quality management. We love seeing specific examples of how you've ensured compliance and improved processes in previous roles.
Apply Through Our Website:Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team at The Royal Marsden!
How to prepare for a job interview at The Royal Marsden
✨Know Your Regulations
Familiarise yourself with the key regulations like UK MRD, ISO 13485, and IEC 62304. Be ready to discuss how your experience aligns with these standards and how you can help the team maintain compliance.
✨Showcase Your QMS Experience
Prepare examples of how you've developed or maintained Quality Management Systems in previous roles. Highlight specific challenges you faced and how you overcame them to ensure quality and safety.
✨Collaborative Mindset
Emphasise your ability to work with diverse teams. Think of instances where you successfully collaborated with different departments to achieve a common goal, especially in a clinical or research setting.
✨Ask Insightful Questions
Prepare thoughtful questions about the role and the organisation's approach to SaMD quality management. This shows your genuine interest and helps you gauge if the environment is the right fit for you.
