Head of Device Data Management – £ 70,011 p.a. + benefits

We are currently looking for a Head of Device Data Management to join our Scientific Data and Insight team within the Safety and Surveillance Group 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 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.  

The main aim of the group is to deliver effectively on our central mission of protecting public health, we need robust vigilance processes that are able to quickly detect, monitor and evaluate safety signals across the product lifecycle, the ability to critically evaluate the benefit/risk balance of signals of concern and design effective risk mitigations, to communicate effectively to patients and the public and a healthcare system able to implement them.  The Safety and Surveillance Group brings together into a single integrated structure expertise on the safety of all medical products with enforcement capabilities. These functions are supported by the Agency’s data and evidence generating capabilities complementing our signal generating abilities delivered via the common vigilance platform SafetyConnect. 

Safety remains at the heart of all our decision making across the product life cycle. The central mission of the Safety & Surveillance portfolio is to protect the public by appropriately identifying, assessing and managing the risks associated with medical products. In every aspect of this work, we harness the best science, technology, information and professional practice to protect patients in new and impactful ways. 

In support of this mission, the Scientific Data & Insight function will be responsible for developing expertise in house to deliver evidence to underpin these new approaches. Quality and speed of regulatory decision making is dependent on having access to high-quality, representative data in a timely fashion but also being able to access and analyse in house data and information in the most effective way. In the future this will include the application of new analytical methodologies including AI and machine learning methods such as natural language processing, large language models and computer modelling and simulation approaches. Hence developing and strengthening capacity and capability in data science within MHRA is a key strategic objective to ensure we are best placed to address the future evidence generation needs for both medicines and devices. 

What’s the role?

The Agency is in the process of developing a new medical device regulatory regime for the GB/UK market together with an underpinning medical device regulatory management IT system which will incorporate a new medical device registration system capturing important master/reference data on: 

• regulatory actors (manufacturers, UK representative persons etc.).  
• all medical devices placed on the UK market under the new regime and linking intelligently into SafetyConnect and other MHRA regulatory management systems. 

In addition, in order to develop a comprehensive post-market surveillance system for devices which can capture long term health outcomes, the postholder will work with external partners and stakeholders to build new data capabilities. 

 Alongside this the post holder will collaborate with colleagues across the Agency to develop a comprehensive market surveillance system underpinned by fit-for-purpose integrated software to ensure the safe and effective use of medical devices.   

The Head of Device Data Management will develop, lead, and manage the performance of the team within the Scientific Data and Insight function to ensure the Agency designs and uses its safety, regulatory and master/reference data to protect patient safety and public health effectively and efficiently.  

The post holder will need work strategically with partners and stakeholders, both nationally and internationally, delivering thought leadership to drive continual improvement in evidence generation for medical device post-market safety surveillance in the UK and globally. 

Key responsibilities: 

•  Develop and lead the implementation of a strategy to ensure that the agency acquires and optimally integrates and processes the data necessary to operate a successful UK and GB medical device regulatory system, as it is developed and established.
• Provide effective leadership and management to the Device Data Management team, to develop staff in line with the Agency’s people and HR strategies and build and inclusive culture of high and continuous performance.  

• Ensuring our systems meets the patient safety and vigilance needs for all safety report types for devices, including user reports and all types of medical device manufacturer market surveillance reports.

• Build and maintain effective partnerships with external stakeholders to ensure effective and appropriate mechanisms for medical device data sharing

Who are we looking for? 

Our successful candidate will: 

• Experience of complex policy development or project management related to information systems involving diverse stakeholders.  
• Experience communicating complex messages to stakeholders across multiple disciplines and professional backgrounds.   
• Experience in the management and/or supervision of professional staff 
• Strong understanding of the medical product regulatory landscape 
• Strong understanding of information systems and data management

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

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• 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 

Job contact :

• Name : The Resourcing Team
• Email : Careers@mhra.gov.uk

Recruitment team

• Email : Careers@mhra.gov.uk