2 of 2 Permanent ISO/IEC 42001 Jobs in Cambridge

processes and systems, implementing best-in-class frameworks to enhance efficiency, compliance, and scalability. Ensure all clinical operations adhere to ICH-GCP guidelines (R2 / R3), applicable regulations, and internal quality standards. Lead the implementation, improvement and validation of new processes, procedures, and IT systems (e.g., eQMS, eTMF … challenges, maintaining agility and compliance in a dynamic environment Requirements Demonstrable experience in regulatory affairs and quality assurance, with a strong focus on software / AI regulation (SaMD / AIaMD) and clinical trial compliance. Deep expertise in ICH-GCP (R2 / R3), ISO 62304, ISO ...

quality and regulatory matters, you will drive innovation, compliance, and transformation across Qureight. Your expertise will ensure that our clinical trial activities, SaMD / AIaMD clearances, biomarker validations, and interactions with regulatory authorities are executed with precision, integrity, and a forward-thinking approach. You will … processes and systems, implementing best-in-class frameworks to enhance efficiency, compliance, and scalability. Ensure all clinical operations adhere to ICH-GCP guidelines (R2 / R3), applicable regulations, and internal quality standards. Lead the implementation, improvement and validation of new processes, procedures, and IT systems (e.g., eQMS, eTMF ...