Clinical Safety Officer

Overview

In this role you will lead clinical risk assessments and act as the clinical safety lead on designated projects, ensuring healthcare technologies are developed and maintained safely. You will bridge clinical practice, product teams and patient safety to support SaMD design, development and post-market activities. You’ll work with a multidisciplinary team to improve patient outcomes through safe digital health solutions. This position offers structured training to grow your expertise in clinical safety within a supportive, technology-driven environment.

Pay / Benefits

• professional development opportunities
• wellbeing support
• recognition programmes
• collaborative environment
• ownership and teamwork
• ongoing training and mentoring

Responsibilities

• Lead and manage clinical risk assessments for assigned products
• Support investigation and resolution of clinical safety incidents
• Contribute to root cause analysis and corrective action planning
• Act as the clinical safety lead for designated projects
• Maintain and update Clinical Safety Files and related documentation
• Ensure compliance with clinical safety standards and regulations
• Support clinical safety and regulatory activities for SaMD (CEPs, CERs, post-market surveillance)
• Collaborate with clinicians, product teams and technical colleagues for safe system development
• Promote clinical safety best practices across the organisation
• Support audits, safety reporting and governance
• Participate in on-call rota for clinical safety advice
• Contribute to patient safety assessments, hazard logs and safety cases

Key requirements

• Registered healthcare professional with minimum five years’ clinical experience in NHS or private settings
• Knowledge of DCB0129 and DCB0160 Clinical Safety Standards and regulatory requirements for SaMD
• Completion of or willingness to undertake an accredited Clinical Safety Officer course
• Experience within NHS informatics or digital healthcare environments
• Familiarity with healthcare technology systems and clinical workflows
• Understanding of project management principles and SDLC
• Strong analytical, communication and problem-solving skills
• Ability to manage competing priorities and make informed decisions
• Commitment to improving patient safety through technology

• Analytical mindset
• Clear communication
• Problem-solving
• SaMD regulatory knowledge (CEPs, CERs, post-market surveillance)
• Clinical safety file documentation
• Risk assessment and hazard analysis

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