Diagnuvo Health Ltd
Head of clinical Safety & Regulatory affairs
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Company Description
Diagnuvo Health Ltd is a UK-based healthtech and deep-tech company developing Diagnuvo ED®, a data-sovereign, real-time clinical intelligence platform for emergency departments and acute care settings.
Our platform is designed to integrate fragmented clinical information, including vital signs, laboratory results, imaging reports and electronic health records, to support early recognition of clinical deterioration and improve situational awareness.
By combining clinical risk assessment, predictive intelligence and workflow integration, Diagnuvo ED® aims to help clinicians recognise patients who may require urgent review, support timely escalation and improve care coordination.
Our approach is clinician-in-the-loop: AI supports clinical decision-making without replacing professional judgment.
We are building technology for one of healthcare's most demanding environments, where timely recognition and communication of clinical risk can make a meaningful difference to patient care.
Key Responsibilities
Clinical Safety & Governance
- Lead clinical risk management activities in accordance with DCB0129, including development and maintenance of the Clinical Risk Management Plan, Hazard Log and Clinical Safety Case Report.
- Oversee hazard identification, risk assessment, mitigation and safety assurance throughout the product lifecycle.
Regulatory Affairs & Compliance
- Support Diagnuvo's UK medical device regulatory strategy, including MHRA engagement, UKCA conformity assessment preparation, technical documentation, clinical evaluation and applicable quality management and risk management requirements.
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Product Safety & Clinical Risk
- Collaborate with engineering, AI and product teams to identify potential clinical hazards, evaluate risk controls and ensure safety requirements are incorporated into product design, development, validation and release processes.
Clinical Evidence & Safety Assurance
- Contribute to clinical evaluation and validation strategies, review safety-related evidence, support usability and human factors assessments, and ensure appropriate documentation and traceability of clinical risk management activities.
Cross-functional Leadership & Stakeholder Engagement
- Work with clinicians, researchers, regulatory specialists and technical teams to establish effective clinical governance processes.
- Support clinical safety reviews, incident management, corrective actions and continuous improvement.
Qualifications & Experience
Essential
- Current registration with an appropriate professional healthcare regulatory body, with relevant clinical experience.
- Demonstrated experience in clinical safety, clinical risk management or clinical governance within healthcare or digital health.
- Knowledge of NHS clinical risk management standards, particularly DCB0129 and DCB0160.
- Experience developing or reviewing clinical safety documentation, including hazard logs, risk assessments and clinical safety cases.
- Understanding of medical device regulatory requirements, clinical evaluation and patient safety principles.
- Ability to work effectively with multidisciplinary clinical, engineering and product teams.
- Strong analytical, documentation, communication and stakeholder management skills.
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Desirable
- NHS Digital Clinical Safety Practitioner training or equivalent relevant training and experience.
- Previous experience as a Clinical Safety Officer or clinical safety lead for a digital health product.
- Experience with ISO 14971, ISO 13485, IEC 62304 or software as a medical device (SaMD) regulatory frameworks.
- Clinical experience in emergency medicine, acute medicine or critical care.
- Experience with AI-enabled clinical decision support, predictive analytics or healthcare interoperability.
- Familiarity with MHRA regulatory processes, clinical investigations and NHS digital health adoption requirements.
Why Join Diagnuvo?
This is an opportunity to help establish the clinical safety and regulatory foundations of an early-stage healthtech company developing AI-enabled clinical intelligence for emergency and acute care.
You will work directly with the founding leadership team and have a meaningful role in shaping how patient safety, clinical governance and regulatory compliance are embedded into the technology from its earliest stages.
Compensation: To be discussed if Selected.
How to apply:
Apply through LinkedIn with your CV and a brief summary of your relevant clinical safety, digital health or medical device regulatory experience.
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