About the job

Job summary

We are currently looking for a Devices Regulatory Lead to join our Software and AI Team within the Healthcare Quality and Access group. 

 

This is a full-time opportunity, on a 12 month fixed term contract/internal move or temporary promotion basis. The role will be based in 10 South Colonnade, Canary Wharf London, E14 4PU. Please be aware that this role can only be worked in the UK and not overseas.   

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 4 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 8 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. Remote working is potentially available for some specific roles. Please discuss this with the recruiting manager before accepting an appointment.   

 

 

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.   

This post is based in the Software and AI Team within Innovative Devices Division of Healthcare Quality and Access.   

Job description

The Software and AI team is responsible for taking all reasonable steps to protect the public health and safeguard the interests of patients by ensuring that software as a medical device (SaMD) meet all appropriate standards of safety and performance and to encourage safe use. The Group does this by providing technical support and advice to the Innovative Devices Regulatory Policy Group; contributes to the review of clinical investigations and compliance activity; and engages with internal and external stakeholders on a range of issues involving software as a medical device. Following the UK exit from the EU, the Software and AI team is now leading on the development of a new regulatory framework for software as a medical device.   

 

   

 

The AI-Airlock project is launching the MHRAs regulatory sandbox, a controlled virtual environment to investigate challenging regulatory questions. The project will explore regulatory science concepts and AI technologies that provide challenges to existing medical device regulatory processes.    

The role will see the post holder interface with other relevant UK regulators of AI for health and social care.    

   

The post holder will need to understand policy developments both domestically and internationally and interpret how they might impact on the delivery of the AI Airlock project. The postholder will need to communicate issues clearly and sensitively with stakeholders, taking account of any nuance, and take steps to safeguard the MHRA regulatory position for AI as it evolves within AI-Airlock and externally. Additionally, the postholder will need to be able to communicate clearly to senior management within MHRA and be particularly alert and able to communicate emerging strategic policy issues that may require discussion and endorsement by Chief Officers for Healthcare Quality and Access and Safety and Surveillance, MHRA Executive Committee, and MHRA CEO.   

   

Additionally, this post will be key to the development of policy and policy thinking for the regulation of AI as a medical device, taking into account the emerging UK regulatory framework for medical devices and standalone software. The post holder will be able to understand complex issues and present information and data to enable senior MHRA leaders to take necessary decisions. 

 

What’s the role? 

This is an important role acting as the lead for AI-Airlock and the primary interface with associated project stakeholders.  

  

There are three core elements to this role:  

• To lead on technical and regulatory expertise for the AI-Airlock project;  
• To work with colleagues within the project team, innovative devices and across the MHRA to take forward the AI Airlock project and  
•  To ensure the delivery of the AI Airlock project objectives, working alongside operational expertise and management 

 

 

Key responsibilities:  

• Support the Project owner, Head of Software and AI, and wider MHRA senior staff on delivering the AI Airlock project. Lead and support stakeholder management.  
• Technical and regulatory management of issues in software and AI. Ensure implementation and development of regulations relating to AI as a medical device.  
• Support the senior management to develop cross team working to respond to emerging issues and the development of regulatory positions. Drive a culture of continuous process improvement and a focus on efficiency gains.  
• Ensure that the AI-Airlock contribution of the MHRA is providing value for money and that there is a focus on targeted proactive activities that ultimately can reduce risk to patients and users of AI medical devices. Ensure that all relevant colleagues and units within the AI-Airlock are engaged as required to ensure harmonised working across the organisation.  

Person specification

Who are we looking for?  

• Leadership: Promote diversity, inclusion and equality of opportunity, respecting difference and external experience. Welcome and respond to views and challenges from others, despite any conflicting pressures to ignore or give in to them. Stand by, promote or defend own and team’s actions and decisions where needed. Seek out shared interests beyond own area of responsibility, understanding the extent of the impact actions have on the organisation. Inspire and motivate teams to be fully engaged in their work and dedicated to their role.  
• Seeing the Big Picture: ensure plans and activities in your area of work reflect wider strategic priorities and communicate effectively with senior leaders to influence future strategies. Bring together views, perspectives, and diverse needs of stakeholders to gain a broader understanding of the issues surrounding policies and activities.  
• Working together: Works effectively as part of a multi-disciplinary team to maintain positive working relationships, working across boundaries and adding value through strategic thinking. Appropriate delegation/clarification of work crucial for 'delivery through others'  
• Making effective decisions: Present reasonable conclusions from a wide range of complex and sometimes incomplete evidence. Make decisions. confidently even when details are unclear or if they prove to be unpopular.  
• Able to demonstrate clear reasoning in difficult situations and sound judgement. Proven ability of leading projects/investigations and liaising with stakeholders e.g. DHSC, Approved Bodies and industry  

 

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  

 

Benefits

Alongside your salary of £56,353, Medicines and Healthcare Products Regulatory Agency contributes £15,215 towards you being a member of the Civil Service Defined Benefit Pension scheme. Find out what benefits a Civil Service Pension provides.

Things you need to know

Selection process details

The selection process: 

 

We use the Civil Service Success Profiles to assess our candidates, find out more here. 

 

• Online application form, including questions based on the Behaviour, Experience and Technical Success Profiles. Please ensure all application questions are completed in full; your application may not be considered if any responses are left blank. Our applications are CV blind, and our Hiring Managers will not be able to access your CV when reviewing your application. 
• Interview, which can include questions based on the Behaviour, Experience, Technical and Strengths Success Profiles. 
• Presentation, to be prepared as part of your interview, with further information being supplied when you reach this stage.

 

 

Applicants are assessed on whether they meet any mandatory requirements as well as the necessary skills and experience for the role. Applications are scored based on the competency-based answers provided- ensure you have read these thoroughly and allow sufficient time. You can view the competencies for this role in the job description. 

 

If you require any disability related adjustments at any point during the process, please contact careers@mhra.gov.uk as soon as possible. 

  

Closing date: 26 February 2024

Interview date: W/C 04 March 2024

 

If you need assistance applying for this role or have any other questions, please contact careers@mhra.gov.uk 

 

Candidates will be subject to UK immigration requirements as well as Civil Service nationality rules. Further information on whether you are able to apply is available here. 

Successful candidates must pass a disclosure and barring security check as well as animal rights and pro-life activism checks. People working with government assets must complete basic personnel security standard checks.

Applicants who are successful at interview will be, as part of pre-employment screening subject to a check on the Internal Fraud Database (IFD). This check will provide information about employees who have been dismissed for fraud or dishonesty offences. This check also applies to employees who resign or otherwise leave before being dismissed for fraud or dishonesty had their employment continued. Any applicant’s details held on the IFD will be refused employment. A candidate is not eligible to apply for a role within the Civil Service if the application is made within a 5 year period following a dismissal for carrying out internal fraud against government.

Any move to the MHRA from another employer will mean you can no longer access childcare vouchers. This includes moves between government departments. You may however be eligible for other government schemes, including Tax-Free Childcare. Determine your eligibility here.

 

Successful candidates may be subject to annual Occupational Health reviews dependent on role requirements. If you have any queries, please contact careers@mhra.gov.uk.

 

In accordance with the Civil Service Commissioners’ Recruitment Principles our recruitment and selection processes are underpinned by the requirement of selection for appointment on the basis of merit by a fair and open competition. If you feel your application has not been treated in accordance with the Recruitment Principles and you wish to make a complaint, you should firstly contact Mira Mepa, Head of Recruitment and Operations, Mira.Mepa@mhra.gov.uk.  

 

If you are not satisfied with the response you receive, you can contact the Civil Service Commission at: civilservicecommission.independent.gov.uk 

 

info@csc.gov.uk 

Civil Service Commission 

Room G/8 

1 Horse Guards Road 

London 

SW1A 2HQ 

 

 

Feedback will only be provided if you attend an interview or assessment.

Security

Successful candidates must undergo a criminal record check. People working with government assets must complete baseline personnel security standard (opens in new window) checks.

Nationality requirements

This job is broadly open to the following groups:

• UK nationals
• nationals of the Republic of Ireland
• nationals of Commonwealth countries who have the right to work in the UK
• nationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities with settled or pre-settled status under the European Union Settlement Scheme (EUSS) (opens in a new window)
• nationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities who have made a valid application for settled or pre-settled status under the European Union Settlement Scheme (EUSS)
• individuals with limited leave to remain or indefinite leave to remain who were eligible to apply for EUSS on or before 31 December 2020
• Turkish nationals, and certain family members of Turkish nationals, who have accrued the right to work in the Civil Service

Further information on nationality requirements (opens in a new window)

Working for the Civil Service

The Civil Service Code (opens in a new window) sets out the standards of behaviour expected of civil servants.

We recruit by merit on the basis of fair and open competition, as outlined in the Civil Service Commission's recruitment principles (opens in a new window). The Civil Service embraces diversity and promotes equal opportunities. As such, we run a Disability Confident Scheme (DCS) for candidates with disabilities who meet the minimum selection criteria. The Civil Service also offers a Redeployment Interview Scheme to civil servants who are at risk of redundancy, and who meet the minimum requirements for the advertised vacancy.