Head of Device Data Management

3 months ago


London, United Kingdom Medicines and Healthcare products Regulatory Agency Full time

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.

**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.
- Support effective partnerships with external stakeholders to ensure that MHRA provides the necessary



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