Benefit Risk Evaluation Assessor – Decontamination and Infection Control

We are currently looking for a Benefit Risk Evaluation Assessor – Decontamination & Infection Control to join our Benefit Risk Evaluation I Team within the Safety & Surveillance 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.  

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. 

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 Safety and Surveillance (S&S) 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. 

Against this background and the drive to improve treatment availability for patients, 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 Benefit Risk Evaluation Assessor – Decontamination & Infection Control role is a critical component of Safety and Surveillance. Reporting to the Biosafety, Nonclinical and Emerging Technologies TAU Head, the assessor will provide technical and regulatory expertise on sterilisation 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 sterilisation issues. Additionally, the post holder will also lead on the assessment of sterilisation for clinical investigations and where appropriate, the development of guidance.

Key responsibilities: 

• Actively participate in meetings and work programmes to assess and investigate safety signals involving sterilisation; 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 sterilisation to other colleagues and senior officials to meet divisional business needs and targets. 

• Undertake technical reviews of sterilisation issues as required on new and emerging safety signals and/or new and emerging data/evidence and make recommendations for actions to protect patients. 

• Commitment to continuous development in the area of sterilisation 

Who are we looking for? 

Our successful candidate will have the following: 

• 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. 
• Knowledge or practical experience of medical devices
• Experience of critically analysing complex clinical/scientific/technical information from a number of sources under pressu