Location
10 South Colonnade, Canary Wharf, London, E14 4PU

Hours
Full Time - 37 hours per week

Salary
£60,778 - £68,422 per annum plus benefits

About the Role
We are seeking two IVD Assessors to join our Clinical Investigations Function within the Scientific Research and Innovation group at the Medicines and Healthcare Products Regulatory Agency (MHRA). This permanent, full-time role involves leading the review and approval of In Vitro Diagnostics (IVDs) used in clinical trials for medicines and supporting the ongoing development and implementation of Diagnostics and Medical Device regulations.

The role is based in London with a flexible, hybrid working model requiring a minimum of 8 days per month on site, with potential to increase to 12 days depending on business needs. The MHRA is committed to enabling collaboration and contact with partners and stakeholders to deliver its business effectively.

The Clinical Investigations and Trials function provides pragmatic, patient-centred advice and assessment of clinical investigations into the performance and safety of medical devices and diagnostics, as well as clinical trials of investigational medicinal products.

Experience
- Extensive knowledge of IVD Directives, EU IVDR, UK MDR and Clinical Trials regulations
- Substantial experience in policy, advisory or product development roles
- Experience working in clinical, medical or toxicology laboratories
- Prior experience with manufacturing and/or research and development of IVD medical devices
- Experience leading technical aspects of regulatory or clinical affairs

About you
You will have excellent verbal and written communication skills with the ability to convey technical information clearly to diverse stakeholders. You will demonstrate strong leadership, effective communication and influencing skills, and the ability to deliver at pace.

You should be adaptable to a hybrid working environment and committed to maintaining high standards of regulatory practice.

Qualifications
- Minimum Master's degree in a relevant discipline such as biochemistry, biomedical engineering, or medicine
- A PhD in a relevant discipline is desirable