Head of Quality Assurance and Regulatory Affairs

Qureight

Head of Quality Assurance and Regulatory Affairs at Qureight. Leading quality transformations and regulatory strategies for clinical imaging and AI-enabled services.

Posted 7/23/2026full-timeCambridge • 🇬🇧 United KingdomLeadWebsite

Core Competencies

Role fit

Core Competencies

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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 ExpertiseQuality Management System (QMS) ImplementationICH-GCP ComplianceISO Standards KnowledgeRisk-Based Quality Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsBiomarker ValidationSoftware RegulationClinical Trial ComplianceQuality AssuranceProject ManagementData AnalysisTraining Development

Soft Skills

Problem-SolvingAnalytical SkillsCommunicationCollaborationStakeholder Management

Tools & Technologies

EQMSETMFClinical Data Management Systems

Industry Keywords

SaMDAIaMDFDAMHRAISO 62304ISO 82304ISO 14971ISO 13485ISO 27001ISO 42001

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

- 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

What you’ll need

- 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.

Benefits

Comp & perks

**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.