Regulatory Affairs Manager
- Location
- Cambridge, England, United Kingdom
regulatory compliance activities. Conduct regulatory impact assessments and provide guidance on product, manufacturing and quality system changes. Work collaboratively with R&D, Software, Bioinformatics, Clinical and Quality teams to ensure regulatory requirements are integrated into product development. Support regulatory submissions, Notified Body interactions and market access activities within … paced development environment. Excellent written and verbal communication skills in English. Desirable Experience with Class C IVDs under IVDR. Experience supporting AI-enabled or bioinformatics-driven diagnostic technologies. Experience with analytical performance, clinical performance and scientific validity studies. Experience with UKCA, FDA or other international regulatory frameworks. Previous experience acting ...