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

Hours
Full Time, Permanent. Hybrid working with a minimum of 8 days per month on site, flexible up to 12 days depending on business needs.

Salary
Negotiable

About the Role
We are seeking two IVD Assessors to join the Clinical Investigations Function within the Scientific Research and Innovation group. The 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. Key responsibilities include reviewing clinical trial applications with IVD or companion diagnostic components, liaising with clinical trials and investigations teams, providing scientific and technical expertise to inform regulatory decisions, and collaborating with stakeholders on use cases. This role is pivotal in ensuring the safety and performance of medical devices and diagnostics through effective regulation and patient-centred advice.

Experience
- Extensive knowledge of IVD Directives, EU IVDR, UK Clinical Trials regulations, and UK MDR (2002) (Part IV).
- 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
- Strong communicator with excellent verbal and written skills, able to convey technical information to diverse stakeholders.
- Demonstrates leadership and the ability to deliver at pace.
- Committed to working collaboratively within a hybrid environment.
- Motivated to contribute to public health through regulatory excellence.

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