JOB SUMMARY

We are currently looking for an AI Regulation, Policy and Projects Lead to join our Innovative Devices Function within the Healthcare Quality 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.

PERSON SPECIFICATION

Our successful candidate will have:

• Skills to develop and implement complex policy involving diverse stakeholders.
• Operational experience working in a regulatory environment and with a focus on software and AI as a medical device.
• Experience working in the software and AI regulatory space within national and international working groups and boards.
• Highly developed interpersonal and influencing skills and the credibility to build excellent relationships and networks with key stakeholders across organisational boundaries.
• A strong and inclusive team leadership style, confident in both people leadership and policy development in an operational context.

If you would like to find out more about this fantastic opportunity, please read our Job Description and Person Specification!
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IN THE INSTANCE THAT WE RECEIVE A HIGH NUMBER OF APPLICATIONS, WE WILL HOLD AN INITIAL SIFT BASED ON THE LEAD CRITERIA OF THE IDEAL CANDIDATE WILL HAVE DEMONSTRABLE EXPERIENCE OF DELIVERING IN THE SOFTWARE AND AI SPACE WITHIN NATIONAL AND INTERNATIONAL REGULATORY WORKING GROUPS AND BOARDS.

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?

This industry engagement and regulatory sandbox exercise requires a leader with excellent stakeholder management skills paired with regulatory and technical knowledge. The post holder will lead a team of specialists, setting clear objectives for that team and supporting them to deliver. The post holder will have a key focus on review and development of the Agency’s AI as a medical device regulatory strategy, ensuring these products can quickly and safely impact patient care, are regulated accordingly to their risk profile, and that recommendations in the Independent Medicines and Medical devices safety review (IMMDSR) are addressed.
The post holder will ensure that timely and appropriate team leadership and specialist input is provided to the development and implementation of the new regulations and supporting guidance to ensure they are fit for purpose, working in collaboration with colleagues across the Agency, in particular in the Partnerships portfolio, Government Legal Department and Department of Health and Social Care. They will represent the Agency in national and international forums, working to support access and uptake and to harmonise international regulatory approach. They will also lead the team in responding to enquiries and support the surveillance structures that enforce regulations and guidance in this rapidly evolving space.

KEY RESPONSIBILITIES:

• The post holder will lead a team of up to 15 people, creating a sense of purpose for the team through highlighting connections between our work and the impact on patients and the public.
• Represent the Agency in national and international meetings and working groups, to harmonise regulatory approaches to AI and ML as a medical device.
• The post holder will lead on the Agency’s AI regulatory policy strategy and implementation, including delivery of the AI Airlock programme, as well as supporting the Head of Software and AI to develop and implement regulatory policy.
• Work to unify workstreams across government, spot opportunities and break down silos.