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. About the role 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. Key Responsibilities Regulatory Leadership & Strategy 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. Quality Transformation & Compliance 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 Cross-Functional Collaboration & Leadership 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 regulatory expectations. Risk Management & Continuous Improvement Oversee a robust risk management framework that ensures proactive identification, assessment, and mitigation of quality and compliance risks across all operations. Drive a data-informed approach to continuous improvement, leveraging quality metrics, trends, and industry benchmarks to shape strategic priorities and operational excellence. Champion a risk-based quality culture, ensuring accountability, transparency, and resilience in all processes, systems, and teams. Ensure the organisation anticipates and adapts to evolving regulatory and quality challenges, maintaining agility and compliance in a dynamic environment 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 82304, ISO 14971, ISO 34971, ISO 13485, ISO 27001, and ISO 42001, with a proven track record of successful regulatory submissions and clearances. Experience of biomarker validation pathways, Extensive experience in leading quality transformations, including the design and implementation of QMS, SOPs, and IT systems (e.g., eQMS, eTMF). Strong background in risk-based quality management, with the ability to balance compliance with operational efficiency. Experience in interacting with regulatory authorities (e.FDA, MHRA, IMDRF) and leading audits/inspections. Proven ability to develop and deliver training programs on GCP, ISO standards, and regulatory requirements. Excellent problem-solving, analytical, and project management skills, with a strategic mindset and execution-focused approach. Superb communication, collaboration, and stakeholder management abilities, with the gravitas to influence at all levels. It’s a bonus if you have the following: Experience of digital biomarker validation, especially in medical imaging. Experience with clinical imaging technologies, workflows, or core lab operations. Familiarity with DICOM standards, imaging protocols, or clinical data management systems. Qualifications & Education Educated to Bachelor's degree level or equivalent in a relevant scientific, technical, or regulatory discipline. Certified to Practitioner level or above as a quality professional (e.g., PCQI, RAC, or equivalent). It’s a bonus if you have the following: Training and experience as an Internal Auditor Are a member of international standards setting committees or regulatory trade bodies. What can you expect from us A comprehensive benefits package that includes an annual bonus plan, private medical insurance, life insurance, and a contributory pension scheme 25 days annual leave, plus bank holidays and enhanced maternity leave A diverse work environment that brings together experts in many fields, including software engineering, devops, data science, machine learning, quality assurance, regulatory affairs, and clinical operations. If you have any queries, please contact View email address on click.appcast.io. Everyone is welcome at Qureight. We are an equal opportunities employer and encourage applications from all suitably qualified candidates regardless of age, disability, ethnicity, sex, gender reassignment, religion or belief, sexual orientation, marriage and civil partnership, or pregnancy and maternity. Women and other underrepresented groups may be less likely to apply for a role unless they meet all or nearly all of the requirements. If this applies to you, we still encourage you to apply – you may be a great fit, even if you don’t meet every qualification. We’d love to hear from you. If you require any adjustments to the application or selection process, please let us know. We will be happy to support you. #J-18808-Ljbffr Qureight Ltd