Technical Lead – Digital mental health - £27,696 p.a. (pro-rata to £46,160 p.a full time equivalent) + benefits

London

Job Summary We are currently looking for a Technical Lead – Digital mental health to join our Digital mental health project team which is part of the Innovative Devices function within the Health Quality and Access group.

This is a part-time opportunity (0.6 FTE/3 days a week), on a fixed term contract until 31st October 2028, internal move, temporary promotion, loans will be considered . The role will be based in 10 South Colonnade, Canary Wharf London, E14 4PU.

Government departments and agencies are working towards implementing a minimum 60% attendance in office sites.

We are currently implementing a flexible, hybrid way of working, with a minimum of 8 days per month working on site to enable the collaboration and contact with partners and stakeholders needed to deliver MHRA business. Attendance on site is driven by business needs so depending on the nature of the role, this can flex up to 12 days a month, with the remainder of time worked either remotely or in the office. Some roles will need to be on site more regularly.

Who are we? The Medicines and Healthcare products Regulatory Agency enhance and improve the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research.

The Innovative Devices function is leading on the development of a new regulatory framework for the UK, which protects patient safety whilst enabling innovation. It also works to improve pre-market support for medical device manufacturers and developers and facilitate a smooth passage to market access through improved regulation and guidance along with tailored support for innovative products across med-tech, diagnostics and digital, or where there is higher associated risk. The function will ensure that the UK has supply of new and advancing medical devices to include software and AI as a medical device, novel implantable devices and diagnostics and play a significant role in developing the new Regulatory Framework for Medical Devices.

Job Description What’s the role? This role is an exciting opportunity to support phase 2 of a Wellcome Trust funded project to ensure that digital mental health products are regulated in a risk proportionate manner and evaluated consistently so users have access to safe and effective products, which could help improve mental health care significantly.

The successful candidate, as a member of the Digital Mental Health project team, will contribute and support senior colleagues on the development and implementation of all aspects of the Wellcome funded programme including the design and delivery of the forthcoming DMHT AI regulatory sandbox, business as usual compliance activities as well as other key deliverables of the Wellcome funded project.

They will support engagement and partnerships with key internal and external stakeholders, including other government departments, professional bodies, trade associations and the wider health sector to ensure UK patients have access to safe and effective Medical Devices.

The post holder will work collaboratively and where appropriate in a matrix model with the safety and surveillance team to establish processes for and support compliance activity on digital mental health technologies available on the UK market to ensure patient safety.

Key Responsibilities:

• contribute and support senior colleagues on the development and implementation of the DMHT AI Airlock as well as other key deliverables of the Wellcome funded project.
• support engagement and partnerships with key internal and external stakeholders, including other government departments, professional bodies, trade associations and the wider health sector to ensure UK patients have access to safe and effective Medical Devices designed for mental health.
• work collaboratively and where appropriate in a matrix model with the safety and surveillance team to establish processes for and support compliance activity on digital mental health technologies available on the UK market to ensure patient safety.
• actively contribute towards ongoing improvement and a positive working environment within the project team and throughout the wider Agency

Who are we looking for? Our Successful Candidate Will Demonstrate The Following:

• Proven customer service skills to deal confidently and diplomatically with external stakeholders and colleagues at all levels. Explain complex issues in a way that is easy to understand.
• Experience of a flexible and adaptable attitude towards work, providing a proactive service and the ability to use initiative, foresight, and have a willingness to go the ‘extra mile’ and excellent attention to detail.
• Regularly monitor your own and team’s work against milestones ensuring individual needs are considered when setting tasks
• Previous experience in software, AI or medical device regulation, including in a clinical, commercial, academic or policy setting. This could include experience developed through previous roles in Regulatory Affairs, Quality Assurance or Medical Affairs.
• Bachelor’s degree of equivalent in a scientific, engineering or medical discipline

What’s the role? This role is an exciting opportunity to support phase 2 of a Wellcome Trust funded project to ensure that digital mental health products are regulated in a risk proportionate manner and evaluated consistently so users have access to safe and effective products, which could help improve mental health care significantly.

The successful candidate, as a member of the Digital Mental Health project team, will contribute and support senior colleagues on the development and implementation of all aspects of the Wellcome funded programme including the design and delivery of the forthcoming DMHT AI regulatory sandbox, business as usual compliance activities as well as other key deliverables of the Wellcome funded project.

They will support engagement and partnerships with key internal and external stakeholders, including other government departments, professional bodies, trade associations and the wider health sector to ensure UK patients have access to safe and effective Medical Devices.

The post holder will work collaboratively and where appropriate in a matrix model with the safety and surveillance team to establish processes for and support compliance activity on digital mental health technologies available on the UK market to ensure patient safety.

Our Successful Candidate Will Demonstrate The Following:

• Proven customer service skills to deal confidently and diplomatically with external stakeholders and colleagues at all levels. Explain complex issues in a way that is easy to understand.
• Experience of a flexible and adaptable attitude towards work, providing a proactive service and the ability to use initiative, foresight, and have a willingness to go the ‘extra mile’ and excellent attention to detail.
• Regularly monitor your own and team’s work against milestones ensuring individual needs are considered when setting tasks
• Previous experience in software, AI or medical device regulation, including in a clinical, commercial, academic or policy setting. This could include experience developed through previous roles in Regulatory Affairs, Quality Assurance or Medical Affairs.
• Bachelor’s degree of equivalent in a scientific, engineering or medical discipline

Person specification

Method of assessment: A=Application, T=Test, I=Interview, P=Presentation Behaviour Criteria:

• Communicating &​ influencing (A, I)
• Managing a Quality Service (A, I)
• Delivering at Pace (A, I)

Experience Criteria:

• (Essential) Previous experience in software, AI or medical device regulation, including in a clinical, commercial, academic or policy setting. This could include experience developed through previous roles in Regulatory Affairs, Quality Assurance or Medical Affairs. (A, I)
• (Desirable) Experience of developing, evaluating (including analytical validation, clinical studies and trials, or systematic reviews and evidence synthesis) and/or policy development specific to software and AI (A, I)

Technical Criteria:

• (Essential) Bachelor’s degree of equivalent in a scientific, engineering or medical discipline (A)
• (Desirable) A Masters, PhD or equivalent in a scientific, engineering or medical discipline with a preference for mental health (A)
• (Desirable) Knowledge of current UK MDR and EU MDR, understanding of the methodological approaches for artificial intelligence (A)

If you would like to find out more about this fantastic opportunity, please read our Job Description and Person Specification! Please note: The job description may not open in some internet browsers. Please use Chrome or Microsoft Edge. If you have any issue viewing the job description, please contact careers@mhra.gov.uk Alongside your salary of £46,160, Medicines and Healthcare Products Regulatory Agency contributes £13,372 towards you being a member of the Civil Service Defined Benefit Pension scheme. Find out what benefits a Civil Service Pension provides (opens in a new window).

• Annual Leave: 25 days annual leave on entry, rising by one day for each completed year of service to a maximum of 30 days and pro-rata for part-time staff. PLUS 8 bank holidays
• Privilege Leave: 1 day
• Hours of Work: 37 hours (net) per week for full time staff in all geographical locations, including London and pro rata for part-time staff
• Occupational Sick Pay (OSP): One month full pay/one month half pay on entry, rising by one month for each completed year of service to a maximum of five months full pay/five months half pay
• Mobility: Mobility clause in contracts allowing staff to