We are seeking a proactive individual with experience of medical device design regulatory processes to join our team and assist in the translation of our research.
The post holder will be based in the School of Biomedical Engineering and Imaging Sciences, King's College London. Located within a hospital environment, our mission is to generate tangible clinical and commercial translation through our stimulating collaborations to achieve the unexpected, and advance research, innovation and teaching progress through our shared mission of engineering better health for patients worldwide. The Senior Quality and Regulatory Engineer will have the opportunity to work on a wide variety of projects in the development of new class I to class III medical devices and healthcare technology.
You will join a growing Quality Team and work with clinicians, researchers and students in a clinical academic setting to ensure the design of medical devices meets regulatory, quality and safety standards for transfer to the clinic to be used in first-in-human studies and regulatory submissions.
The Quality Team have established the Medical Engineering Quality Management System (QMS) to meet the requirements of ISO 13485 and support the operation of the new facility for the Manufacture of Active Implants and Surgical Instruments (MAISI) and the development of state-of-the-art medical technology, including surgical robotics, imaging software and AI.
The post holder will be expected to guide various project teams in quality system procedures, identifying gaps in project information and processes; recommending solutions, and be responsible for developing and maintaining compliant development processes and technical documentation that meet the needs of the different stakeholders within and external to the organisation.
This post will be offered on a fixed-term contract for 2 years
This is a full-time post - 100% full time equivalent
• Work with and guide project teams to ensure that correct processes are followed during the design and development of medical devices to facilitate demonstration of quality and safety requirements and meet regulatory expectations for the translation of academic research to the clinic.
• Review documentation of the projects' design and development activities, as well as risk management and technical files to ensure compliance with procedures.
• Review requirements, specifications and technical design documents for traceability and testability.
• Lead project teams in risk management activities according to ISO 14971.
• Participate as quality representative in Design Reviews.
• Develop, review or approve inspection, test methods, verification and validation test protocols and reports, for design projects and manufacturing processes as required.
• Perform or witness verification and validation testing as required.
• Work with internal and external manufacturing teams to transfer technologies for prototype production.
• Support technology transfer to industrial entities following licencing of technologies developed within academic quality management system.
• Work with other members of the quality team to ensure project teams have the appropriate regulatory strategy for their project.
• Support quality system resource management and perform project management tasks including updating the project register.
• Work in collaboration with other members of the quality team to develop and maintain fit for purpose, compliant quality system processes.
• Contribute to the development and implementation of standard operating procedures, tools, templates and guidance.
• Provide training in the quality system, design and risk processes.
• Perform document control activities including creating, distributing, retaining, modifying, reviewing and approving documents and records.
• Conduct supplier evaluations and monitoring. Ensure supplier agreements are in place where required for new device development.
• Carry out internal audits and participate in notified body audits.
• Contribute to the completion of non-conformance, corrective and preventive actions. Lead root cause analysis as required.
The above list of responsibilities may not be exhaustive, and the post holder will be required to undertake such tasks and responsibilities as may reasonably be expected within the scope and grading of the post.
Skills, knowledge, and experience
1. Degree or equivalent experience in engineering discipline (biomedical, software, electronic, mechanical, materials), quality or related subject.
2. Knowledge and experience applying quality system standards and regulation, e.g. ISO 13485, 21 CFR 820, AIMD, MDD and MDR.
3. Knowledge and experience using risk management standards applied to design activities e.g. ISO 14971.
4. Experience in the application of design controls, e.g. writing or reviewing design plans, requirements, verification and validation protocols and reports.
5. Experience of working to quality system procedures.
6. Experience of preparing and writing standard operating procedures, templates and/or test method instructions.
7. Experience of project or task prioritisation, able to handle several projects at once.
8. Excellent organisational, written and verbal communication skills and ability to troubleshoot.
9. Ability to work collaboratively with different teams to agreed deadlines.
10. Ability to understand regulatory needs and problem solve.
1. Knowledge and experience of development and testing standards applied to medical devices e.g. ISO 62366, IEC 62304, IEC 60601 series, or ISO 10993 series.
2. Line management, teaching, supervision and / or mentoring experience
3. Auditing experience
4. Experience in preparing regulatory submissions
When applying, in the “Upload supporting documents” section, please ensure that you attach a personal statement to demonstrate why you are suitable for the role based on the essential criteria.
The selection process will include a presentation and a panel interview. Presentations scheduling will be confirmed once shortlisting has taken place and may be held online.