JOB SUMMARY

We are currently looking for an AI Regulation, Innovation and Sandbox Lead 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. We are open to requests for flexible working. Please discuss this with the recruiting manager before accepting an appointment.
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.

JOB DESCRIPTION

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 implantable devices and diagnostics and play a significant role in developing the new Regulatory Framework for Medical supply of safe, new and advancing medical devices to include software and AI as a medical device, novel Devices.

PERSON SPECIFICATION

Our successful candidate will demonstrate the following:

• Leadership - An effective leader, visible, empowering others, building resilience and leading improvements with the ability to motivate high performing teams to success, adapting your leadership style where appropriate and delivering through others. Welcome and respond to views and challenges from others, despite any conflicting pressures to ignore or give in to them.
• Communicating and Influencing - communicate with others in a clear, honest and enthusiastic way in order to build trust. Explain complex issues in a way that is easy to understand. Take into account people’s individual needs. Deliver difficult messages with clarity and sensitivity, being persuasive when required. Consider the impact of the language used. Remain open-minded and impartial in discussions, whilst respecting the diverse interests and opinions of others. Introduce different methods for communication, including making the most of digital resources whilst getting value for money. Monitor the effectiveness of own and team communications and take action to improve where necessary
• Changing and Improving – Seek out opportunities to create effective change and suggest innovative ideas for improvement. Can make changes which add value and clearly articulate how changes will benefit the business. Understand and identify the role of technology in public service delivery and policy implementation
• Seeing the Big Picture – Develop and maintain an understanding of economic, social, political, environmental and technological developments to ensure activity is relevant. Ensure plans and activities in your area of work reflect wider strategic priorities and communicate effectively with senior leaders to influence future strategies. Adopt a government and MHRA wide perspective.
• Delivering at Pace - ensure everyone clearly understands and owns their roles, responsibilities and business priorities. Give honest, motivating and enthusiastic messages about priorities, objectives and expectations to get the best out of people. Comply with legal, regulatory and security requirements in service delivery. Set out clear processes and standards for managing performance at all levels. Ensure delivery of timely quality outcomes, through providing the right resources to do the job, reviewing and adjusting performance expectations and rewarding success. Maintain your own levels of performance in challenging circumstances and encourage others to do the same

If you would like to find out more about this fantastic opportunity, please click here to read our Job Description and Person Specification!
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SELECTION PROCESS DETAILS

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.

In the instance that we receive a high number of applications, we will hold an initial sift based on the lead criteria of Leadership.
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.

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)
• 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

WHAT’S THE ROLE?

The post holder will lead the AI Airlock within the Software and AI regulations team. They will work with industry, academics, legal and regulatory experts and patient representatives to extract valuable information on regulatory issues facing innovative software products.
They will also be responsible for working with other members of the broader Software and AI regulations team to ensure that this information quickly and efficiently enters our guidance and regulatory processes.
Finally, they will be responsible for liaising more broadly across government (both with other regulators and with groups like the Regulatory Innovation Office) to ensure that regulatory excellence is exported from and imported into MHRA

KEY RESPONSIBILITIES:

• Provide strategic leadership for the continued development and delivery of the AI Airlock, leveraging evidence gained to deliver tangible improvements in regulatory practice, while also feeding back into the Airlock itself and improving its practice
• Lead relationships with other innovative regulatory areas to ensure the MHRA understands and internalises best practices across government while promoting the reputation and practices of the MHRA to a wide audience
• Line manage a team as appropriate, ensuring team members are both accountable and empowered to make decisions to innovate. Role modelling continuous self-learning and development is also essential.
• Establish strong relationships with a network of both internal and external stakeholders – such as DHSC Sponsor and policy teams, other Government departments, industry trade associations, and other regulators – to build bringing different perspectives together to understand policy and technical challenges creating a shared sense of purpose to maximize the impact of our work for the benefit of patients and the public. Confidently leading representational work with senior stakeholders, which may include representing the MHRA at external meetings, conferences and events.