Head of Quality Assurance and Regulatory Affairs

• 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 regulatory expectations.
• 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

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 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.g.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.

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 training programs while ensuring compliance and operational efficiency.

Highest-signal resume keywords

• Regulatory Affairs Expertise
• Quality Management System (QMS) Implementation
• ICH-GCP Compliance
• ISO Standards Knowledge
• Risk-Based Quality Management

ATS Optimization Keywords

Hard Skills

• Regulatory Submissions
• Biomarker Validation
• Software Regulation
• Clinical Trial Compliance
• Quality Assurance
• Project Management
• Data Analysis
• Training Development

Soft Skills

• Problem-Solving
• Analytical Skills
• Communication
• Collaboration
• Stakeholder Management

Industry Keywords

• SaMD
• AIaMD
• FDA
• MHRA
• ISO 62304
• ISO 82304
• ISO 14971
• ISO 13485
• ISO 27001
• ISO 42001

Tools & Technologies

• EQMS
• ETMF
• Clinical Data Management Systems

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