Head of Quality Assurance and Regulatory Affairs
- Hiring Organisation
- Jobleads-UK
- Location
- Cambridge, England, United Kingdom
anticipates and adapts to evolving regulatory and quality 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/… imaging technologies, workflows, or core lab operations. Familiarity with DICOM standards, imaging protocols, or clinical data management systems. Demonstrates expertise in regulatory affairs and quality assurance, particularly in software and AI regulation, with a strong focus on ICH-GCP and ISO standards. Proven ability to lead quality transformations and develop ...