Regulatory Affairs Manager
- Location
- Cambridge, England, United Kingdom
growth and success of our dynamic and forward-looking company. As we progress towards commercialising a test for CRC, we are looking for a Regulatory Manager to lead the development process through relevant regulatory pathways. Responsibilities: Lead Regulatory Affairs activities for medical devices, in vitro diagnostic medical … software as an IVD (SaMD) and genomic diagnostic technologies. Develop, maintain and update Technical Documentation in accordance with EU MDR, IVDR and other applicable regulatory requirements. Support the development and implementation of regulatory strategies for new product development, product changes and lifecycle management. Prepare and maintain regulatory ...