Overview

Medical Devices Governance Specialist – Strand, London, WC2R 2LS

About us

Research and innovation are at the heart of King’s College London’s mission to make a positive difference in the world. The Research Management & Innovation Directorate (RMID) leads this ambition by shaping and enabling the university’s research and innovation agenda, ensuring an environment in which our researchers, professional staff and doctoral students can excel. This work is guided by King’s Strategy 2030, which emphasises academic excellence, real‑world impact, and a culture where research and innovation can truly thrive.
 
The Department of Research Governance, Ethics and Integrity (RGEI) plays a critical role in safeguarding the quality and credibility of King’s research. 
 
The department ensures that all research conducted across the university is safe, ethical, lawful and carried out to the highest standards of integrity and rigour. Our teams develop and deliver policies, systems, guidance, training and initiatives that support researchers in navigating ethical and regulatory requirements, enabling them to conduct high‑quality research with confidence while feeling supported and valued.

About the role

This new specialist role sits within the recently developed King’s College London (KCL) Clinical Research Hub, jointly led by the Department of Research Governance, Ethics and Integrity (RGEI), King’s Clinical Trials Unit (KCTU) and Research Pre-Award and Contracts. This post will be based within the Research Governance Office (RGO), reporting to the Clinical Sponsorship and Quality Lead and will support the University’s capacity to Sponsor high-quality, compliant medical device research, strengthening King’s position as a leader in device innovation research.
 
The post holder will be the key point of expert advice and support on regulatory and operational requirements for medical device studies sponsored or co-sponsored by King’s on behalf of the Research Governance Office.
 
With the support of the Clinical Sponsorship and Quality Lead, the post holder will develop, coordinate and oversee activities across the full device study lifecycle to ensure proportionate and effective sponsor oversight of King’s medical device portfolio. They will also ensure compliance with relevant legislation and standards, including the UK Medical Devices Regulations 2002, MHRA guidance on clinical investigations, ISO14155 Good Clinical Practice for medical device studies and the UK Policy Framework for Health and Social Care Research, across the full research project life cycle.
 
The post holder will support investigators with the preparation, submission and Sponsor authorisation of MHRA applications and IRAS forms for clinical device trials sponsored by King’s College London. This includes assisting and leading governance reviews for all study types involving medical devices submitted through IRAS and/or the College Ethics system as required.
 
It is expected that the post holder will review and interpret existing technical documentation, declaration of conformity and safety certification to confirm suitability for MHRA and/or ethics submission, with specialist support provided from the King’s Clinical Trials Unit (KCTU) and the Medical Engineering Quality and Regulatory Team (MEQRT) in complex technical, engineering or detailed trial design matters. Opportunities for training and integrated working with both teams will be provided.  
 
This is a full time post (35 hours per week), and you will be offered an indefinite contract.
 
We reserve the right to close the application process early in the event of a large volume of applications.

Before you apply -
Register now and turn on alerts for jobs like this!

  • To apply for this position, receive job notifications and manage your applications, click "Register with Diversity Jobs Group".
  • To apply for this position without registering, click "Apply with Customer".

By registering you agree to our terms and conditions.

Apply with Customer

IMPORTANT: Before applying for this role, please make sure you have the right to work in the country where the role is based. Unless it clearly stipulates within in the job advert above that the hiring company is looking to or able to sponsor applicants it is deemed that the hiring employer will only consider applications from those able to comply with and work in the country where the role is based.