King's College London

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.

About you

To be successful in this role, we are looking for candidates to have the following skills and experience:

Essential criteria 

1.      Degree or professional experience equivalent, with substantial expertise in medical device regulatory and governance requirements for clinical research. Applicants may come from scientific, engineering, industry, quality or regulatory backgrounds.

2.      In-depth knowledge of UK medical device regulations including device classification, MHRA requirements, UK Medical Devices Regulations 2002, and ISO 14155.

3.      Experience supporting or leading regulatory submissions (e.g., MHRA applications for clinical investigations or equivalent regulatory interactions).

4.      Demonstrated experience in research governance, regulatory or clinical research operations, preferably within a Sponsor, CTU, NHS Trust or academic setting.

5.      Strong stakeholder engagement skills, with the ability to build effective working relationships with technical specialists, investigators and support services, with proven problem-solving capability

6.      Strong organisational and problem‑solving abilities, with the ability to manage a varied workload, work independently, and exercise sound judgement.

7.      Experience supporting audit, monitoring or compliance or inspection readiness activities (e.g., internal audits, MHRA inspections, external quality assessments).

8.      Excellent written and verbal communication skills, including the ability to provide clear guidance, training, and documentation to research teams.

Desirable criteria

1.      Experience in medical device quality assurance, regulatory affairs or equivalent position with the responsibility to review, approve and provide guidance.

2.      Experience of clinical governance and/or sponsorship reviews, or post-regulatory amendment reviews

3.      Knowledge of legislation and guidance relevant to Medical Device manufacture, storage, distribution and administration.

4.      Experience contributing to process improvement, policy development or implementation of new governance procedures.

5.      Knowledge of post‑market surveillance requirements and/or safety reporting processes for device studies.

Downloading a copy of our Job Description 

Full details of the role and the skills, knowledge and experience required can be found in the Job Description document, provided at the bottom of the page. This document will provide information of what criteria will be assessed at each stage of the recruitment process.

Further Information

At King’s, we believe that the diversity of our community and a culture that is welcoming, open, inclusive and collaborative, are great strengths of the university. 

The Equality Act of 2010 protects the rights of our students and staff and provides a framework to fulfil our duties to eliminate unlawful discrimination, harassment and victimisation and in addition, to advance equality of opportunity and foster good relations between those who share a protected characteristic and those who do not. At times, this will include balancing rights and beliefs that can feel in tension.

We are committed to free speech and to academic freedom, believing that our foundational purpose as a university, is to create spaces where a wide range of ideas, including ideas that are controversial, can be discussed and debated, and where members of our community can express lawful views without fear of intimidation, harassment or discrimination.

When engaging in the robust exchange of ideas, we ask that our community is mindful of our Dignity at King’s guidance.

We ask all candidates to submit a copy of their CV, and a supporting statement, detailing how they meet the essential criteria listed in the person specification section of the job description. If we receive a strong field of candidates, we may use the desirable criteria to choose our final shortlist, so please include your evidence against these where possible.

We reserve the right to close adverts early due to the volume of applications we receive. While the closing date may change, all adverts will close at 23:59 to allow sufficient time for applications to be submitted on that day.

We encourage you to apply at the earliest opportunity to avoid disappointment as once we have closed a vacancy you will be unable to submit your application.

To find out how our managers will review your application, please take a look at our ‘How we Recruit’ pages.