"Benefit Risk Evaluation Assessors – Software (x2 roles)"

The MHRA is transforming. Through enabling innovation, making the right judgements of the benefits and risks of medical products and forging the right partnerships in the UK and internationally, it aims to deliver world class regulation and improved outcomes for UK patients.

We are currently looking for experienced Benefit Risk Evaluation Assessors to join our Benefit/Risk Evaluation Team II in the Safety and Surveillance group.

Within a week of working here, your day could look like this: Provide technical and regulatory expertise and leadership on software as a medical device to the Benefit Risk Evaluation Group, the Software and AI Group and across the wider MHRA. The post holders are required to use a range of data sources to undertake trending activities and identify safety signals for further investigation. Additionally, post holders will also contribute to the development of the regulatory framework for software as a medical device.

• Actively participate in meetings and work programmes to assess safety signals involving software as medical devices; effective management of trending activities and safety signal reports ensuring cases are kept up-to-date and quality of work is maintained.
• Provide specialist technical advice and support on software as a medical device to other colleagues and senior officials to meet divisional business needs and targets.
• Undertake technical reviews of software as a medical device as required on new and emerging safety signals and/or new and emerging data/evidence and make recommendations for actions to protect patients.
• Develop and implement regulatory changes on software as a medical device through legislative reform and clarificatory guidance and provide advice and guidance to stakeholders as this evolves.

Closing date: 31 August 2025