About this role
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 I in the Safety and Surveillance group.
Within a week of working here, your day could look like this: provide technical and regulatory expertise on biological safety matters to the Benefit Risk Evaluation Group, the Clinical Investigations Group and across MHRA. The post holder is required to work collaboratively with other benefit risk assessors across the group to provide expert advice and direction to investigations on biological safety issues. Additionally, the post holder will also lead on the assessment of biological safety for clinical investigations and where appropriate, the development of guidance.
The successful candidate will actively participate in meetings and work programmes to assess and investigate safety signals involving biological safety; effective management of safety issues ensuring relevant assessors are kept up-to-date and quality of work is maintained.
Provide specialist technical advice and support on biological safety to other colleagues and senior officials to meet divisional business needs and targets. Undertake technical reviews of biological safety issues as required on new and emerging safety signals and/or new and emerging data/evidence and make recommendations for actions to protect patients.
The successful candidate will have a degree or equivalent qualification in life sciences, health care or engineering (such as medical engineering, toxicology, material science, or healthcare qualification); and previous relevant experience gained in healthcare, medical device manufacturing, regulatory environment, or health data science.
Our successful candidate will have:
Technical knowledge or practical experience of a range of medical devices including knowledge and experience of standards in biological evaluation and risk management of medical devices Experience of critically analysing complex clinical/scientific/technical information from a number of sources under pressure and make appropriate recommendations or decisions to protect patient safety/public health even when the evidence is not clear. Experience of implementing appropriate actions to mitigate risk. Evidence of writing well-structured, concise, authoritative reports to support decision making on device safety and provide technically sound information to stakeholders. Knowledge and understanding of the relevant regulatory frameworks, including provisions related to biological safety