Head of Quality Assurance and Regulatory Affairs

Qureight’s mission is to accelerate clinical trials and ensure breakthroughs in lung and heart disease reach patients without delay. Our AI-powered data and imaging curation platform enables the analysis of clinical imaging and other healthcare data, helping our customers bring treatments to market, faster.

We’re looking for talented people who want their work to matter. With offices in Cambridge and London, you’ll join our multidisciplinary team of clinicians, scientists, and engineers. What unites us is our open culture, continuous learning mindset, and a shared mission to help biopharma run faster, smarter trials.

Qureight is seeking a visionary, transformational leader to serve as our Head of Quality Assurance and Regulatory Affairs. This role is pivotal in shaping the future of our clinical imaging and AI-enabled services, ensuring that our quality systems, processes, and regulatory strategies not only meet but exceed the highest standards of compliance and operational excellence.

As the organisation’s strategic and operational lead for all 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 act as the go-to subject-matter expert for all aspects of software regulation, including ISO 62304, ISO 82304, ISO 14971, ISO 34971, ISO 13485, ISO 27001, and AI-specific guidance such as ISO 42001. Your leadership will embed a culture of quality, efficiency, and continuous improvement, enabling Qureight to maintain its reputation as a leader in imaging core lab services and AI-driven clinical solutions.

This role demands a proactive, results-driven individual who can balance rigorous compliance with pragmatism, speed, and operational excellence. If you are passionate about revolutionising quality processes, leading regulatory strategy, and shaping the future of AI in clinical trials, we want to hear from you.

• Lead the development and execution of Qureight’s regulatory strategy, ensuring alignment with global standards and business objectives.
• Drive regulatory submissions and clearances for SaMD, AIaMD, and biomarker validations, acting as the primary liaison with regulatory authorities (e.g., FDA, MHRA, etc) and notified bodies.
• Design and execute Qureight’s digital biomarker validation strategy in the US and EU markets.
• Provide expert guidance on software regulation, including ISO 62304, ISO 82304, ISO 14971, ISO 34971, ISO 13485, ISO 27001, and ISO 42001, ensuring all systems and processes are compliant.
• Stay ahead of emerging regulations and AI guidance, proactively adapting Qureight’s strategies to maintain a competitive edge.

• Revolutionise Qureight’s quality 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) to support GxP compliance and operational excellence.
• Oversee internal and external audits, including regulatory inspections, ensuring findings are addressed promptly and effectively

• Partner with Clinical Operations, IT, Engineering, and Science Teams to integrate quality and regulatory requirements into digital platforms, AI-enabled solutions, and GxP-relevant systems.
• Embed a culture of quality awareness through training, workshops, and mentoring, ensuring all staff are competent and compliant with GCP, ISO standards, and internal policies.
• Support the Quality Manager in maintaining the Business Management System (BMS) as it relates to GCP and clinical operations.
• Develop and track quality objectives and performance metrics, aligning them with organisational goals and…