Head of Software & AI Medical Devices - £76,000 - £86,450 p.a. + benefits
Medicines and Healthcare Products Regulatory Agency
Apply before 11:55 pm on Monday 14th October 2024
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About the job
Job summary
We are currently looking for a Head of Software & AI Medical Devices to join our Innovative Devices function within the Healthcare Quality and Access group.
This is a full-time opportunity, on a permanent 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 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 group 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 as a medical device, novel implantable devices and diagnostics.
Job description
The primary purpose of this role is to lead the MHRA Software & AI Medical Device teams, to deliver a programme of regulations, guidance and advice across the whole lifecycle of these products.
At a time when the government agenda is to fix the NHS, software as medical devices for treatment and diagnosis, have the potential to transform patient outcomes.
To deliver on that potential, this team of experts require a visionary leader to drive delivery of our Software Roadmap, as well as collaborating with partners in academia, industry, other global regulators or across the civil service and healthcare, to ensure it remains relevant to how Software and AI may be used in the future.
Key responsibilities:
- Drive and engage an implementation programme to deliver a new regulatory system for software and AI medical devices.
- Provide leadership and management to a team of technical and policy specialists, including ensuring robust goals and plans are in place, expectations are clear and team members have the training and support the need to deliver.
- Drive cross sector improvements in the awareness and understanding of how software as a medical device is regulated, working in collaboration with system partners across the Agency, the health family and across Government.
- Lead and develop national and international guidance and frameworks in support of the safe introduction and ongoing oversight of software and AI devices into health settings. As part of this, sustain and further develop relationships with national and international partners, as well as with the manufacturers, users and researchers required to follow and support regulations and policy in this area.
Person specification
- Leadership - a strong and inclusive corporate and team leader, confident in both people leadership and policy development in an operational context, with the ability to empower and motivate others in a dynamic environment and across organisational boundaries and create cultures of high performance and continuous improvement, with an engaging, adaptable, leadership style.
- Communicating & Influencing - highly developed interpersonal and influencing skills and the credibility to build excellent relationships and networks with key stakeholders across organisational boundaries, taking a collaborative approach.
- Experience - Complex policy and strategy development involving diverse stakeholders. Experience of developing software medical devices preferred, through all phases of development and implementation. The ideal candidate will have built productive networks with relevant experts.
- Technical: Bachelor’s degree in a relevant discipline e.g. law, science, engineering, medicine or equivalent experience developed through previous roles. An understanding of the potential and actual applications of software in healthcare and the risks and benefits associated with these and emerging technologies.
If you would like to find out more about this fantastic opportunity, please read our Job Description and Person Specification!
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Benefits
- 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 be mobile across the Civil Service
- Civil Service Pension Scheme. Please see the link for further information http://www.civilservicepensionscheme.org.uk/ For enquiries relating to the Civil Service Pension Schemes please contact MyCSP's Pension Service Centre directly on 0300 123 6666
- Flexible working to ensure staff maintain a healthy work-life balance
- Interest free season ticket loan or bike loan
- Employee Assistance Services and access to the Civil Service Benevolent Fund
- Eligibility to join the Civil Service Motoring Association (CSMA)
- Variety of staff and Civil Service clubs
- On-going learning and development
Things you need to know
Selection process details
We use the Civil Service Success Profiles to assess our candidates, find out more here.
- Online application form, including a statement of suitability, attached as a PDF of no more than 750 words demonstrating how you meet the person specification. 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.Please ensure not to include any personal identifying information on your supporting information.
- Presentation, to be prepared as part of your interview, with further information being supplied when you reach this stage.
- Interview, which can include questions based on the Behaviour, Experience, Technical and Strengths Success Profiles.
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 statement of suitability provided. You can view the criteria for this role in the job description.
Use of AI in Job Applications
Applicants must ensure that anything submitted is factually accurate and truthful. Plagiarism can include presenting the ideas and experience of others, or generated by artificial intelligence, as your own.
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: 14th October 2024
Shortlisting date: 15th October 2024
Interview date: 28th October 2024
Candidates will be contacted within a week of the sift and the interviews completed to inform them of the outcome.
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
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Feedback will only be provided if you attend an interview or assessment.
As part of accepting this role you will be agreeing to the expected assignment duration set out above. This will not result in a contractual change to your terms and conditions. Please note this is an expectation only, it is not something which is written into your terms and conditions or indeed which the employing organisation or you are bound by. It will depend on your personal circumstances at a particular time and business needs, for example, would not preclude any absence like family friendly leave. It is nonetheless an important expectation, which is why we ask you to confirm you agree to the assignment duration set out above.
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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).
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Contact point for applicants
Job contact :
- Name : The Resourcing Team
- Email : careers@mhra.gov.uk
Recruitment team
- Email : Careers@mhra.gov.uk
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