Digital Clinical Safety Officer

Healthcare Business Solutions UK Ltd; Nottingham; On-site; GBP 50,000 - GBP 70,000; Full time

Job summary

A healthcare technology company in the UK is seeking a Digital Clinical Safety Officer to manage the Clinical Risk Management System for software as medical devices. This role requires significant clinical experience, project management skills, and the ability to ensure compliance with NHS Digital Standards. The candidate will act as the primary clinical safety authority, guiding product and technical teams while ensuring the safety and effectiveness of digital health solutions. A degree-level education and professional registration in healthcare are essential.

Qualifications

• Degree-level education or equivalent substantial professional experience.
• Current, active registration with a UK statutory healthcare body (e.g., NMC, HCPC).
• Significant recent clinical experience (NHS Band 6/7 or above).

Responsibilities

• Ensure clinical hazards are identified, assessed, and mitigated.
• Manage the Clinical Risk Management System throughout the product lifecycle.
• Provide expert advice to Product and Technical teams.

Skills

Clinical governance knowledge

Project management skills

Verbal and written communication

Agile methodologies

Education

Degree-level education or equivalent

Current registration with a UK statutory healthcare body

Clinical Safety Accreditation

Job description

HBS’ Digital Clinical Safety Officer (DCSO) will involve two critical digital safety roles in the business, bridging the requirements of the NHS Digital Standards (specifically DCB 0129 for manufacturers) and the rigorous requirements set by the UK Medical Device Regulator (MHRA) and European Regulator for a Class IIa medical device. This requires a specialized skill set that combines clinical knowledge with technical regulatory competence.

The overarching goal alignment is the meticulous establishment, execution, and continuous maintenance of the Clinical Risk Management System (CRMS) for the business’s Software as Medical Device products alongside ensuring that clinical safety is prioritized and embedded throughout the product lifecycle. This alignment is critical because compliance with NHS Digital Clinical Risk Management Standard DCB 0129 is mandatory for any health IT product intended for deployment within the NHS infrastructure, serving as a gateway for market entry and Digital Technology Assessment Criteria (DTAC) approval.

The person appointed will ensure that all clinical hazards are systematically and proactively identified, rigorously assessed, and appropriately mitigated across all development and deployment stages. The person appointed will also use this insight to guide future development of the products.

The business’s DCSO must possess deep technical governance knowledge, including experience with system analysis, development, testing, release, upgrades, and decommissioning. The DCSO must be fluent in translating abstract clinical practice hazards (e.g., poor handoff procedures) into concrete, quantifiable technical software requirements and defined risk mitigation strategies that can be integrated directly into the product’s architecture, often requiring engagement with agile methodologies.

The DCSO will be integrated into the continuous software development cycle, ensuring that every iterative release maintains safety compliance and triggers the necessary updates to the Risk Management File and Hazard Log. This necessity for continuous compliance dictates a high level of operational integration between the DCSO and the technical product teams.

Serve as the officially named, accredited Clinical Safety Officer (CSO) responsible for developing, maintaining, and assuring full organizational compliance with the NHS Digital Clinical Risk Management Standard DCB 0129 for manufacturers.

Own and manage the end-to-end Clinical Risk Management System (CRMS) throughout the entire SaMD product lifecycle, from initial concept and design through development, iterative updates, deployment, and eventual decommissioning.

Act as the organisation's primary clinical safety authority, providing mandatory expert advice and challenge to Product, Technical, Regulatory, and Senior Management teams.

Provide the formal, documented recommendation to Senior Management regarding the clinical safety acceptability and fitness for deployment of the Class IIa SaMD product into live health settings.

This role will report to the Chief Medical Officer.

To be considered for the the role you will require the following:

EDUCATION QUALIFICATIONS & TRAINING

• Degree-level education or equivalent substantial professional experience.
• Current, active registration with a UK statutory healthcare body (e.g., NMC, HCPC, GMC, GPhC).
• Professional Registration
• Dual registration or post-registration clinical specialism (e.g., informatics).
• Clinical Safety Accreditation
• Formal, accredited training as a Clinical Safety Officer (CSO) or willingness to achieve accreditation within 6 months of appointment.

EXPERIENCE

• Significant recent clinical experience (equivalent to NHS Band 6/7 or above) demonstrating a deep understanding of clinical workflows and operational risk.
• Experience in clinical audit or clinical projects directly related to IT systems.
• Proven experience or demonstrable knowledge of the full digital system lifecycle, including system analysis, testing, release, upgrades, and decommissioning.
• Direct, demonstrable experience in establishing and maintaining a Hazard Log, conducting detailed hazard analysis, and drafting Clinical Safety Case Reports.

KNOWLEDGE AND SKILLS

• In-depth knowledge and proven practical application of the NHS Digital Standard DCB 0129 (Manufacturer) and a working knowledge of DCB 0160 (Adopter).
• Excellent verbal and written communication skills, with the ability to articulate highly complex safety issues to multi-professional stakeholders (clinical and technical).
• Strong project management skills, principles, and practices.

EDUCATION QUALIFICATIONS & TRAINING

• Membership or Fellowship of the Faculty of Clinical Informatics (FCI).
• Post-graduate diploma or Master's qualification in Informatics, Patient Safety, or Regulatory Affairs.

EXPERIENCE

• Experience operating within an agile software development environment.

KNOWLEDGE AND SKILLS

• Working knowledge of MHRA guidance on Software as a Medical Device (SaMD) and UK MDR vigilance requirement.

OTHER JOB-RELATED REQUIREMENTS

• Experience utilising formal patient safety investigation methodologies (e.g., RCA or SEIPS).

Within this position, you will mainly be;

Product Development & Design Safety (DCB 0129)

• Hazard Identification & Analysis: Direct and lead systematic cross-functional hazard workshops, utilizing appropriate methodologies (e.g., STAMP or HAZOP), to identify, classify, and analyse potential clinical hazards arising from system use, misuse, or failure, strictly adhering to the DCB 0129 methodology.
• Hazard Log Management: Establish and maintain the centralised Hazard Log and Clinical Risk Management File (CRMF), ensuring detailed traceability is documented between identified hazards, root causes, severity scoring, defined risk control measures, and the resulting residual risk.
• Risk Mitigation Definition: Define precise, auditable, and technically feasible clinical risk control measures, collaborating intensively with engineering and design teams to ensure these controls are embedded directly into software design requirements and verified during technical testing phases.
• Design Input and Review: Ensure clinical safety practices are integrated seamlessly into the company's agile development and Continuous Integration/Continuous Deployment (CI/CD) pipelines, participating in requirement analysis and design reviews to maintain safety compliance throughout iterative development.
• Testing Assurance: Review and formally approve all clinical test specifications and validation plans (e.g., User Acceptance Testing—UAT) to confirm that defined risk controls have been implemented effectively and verifiably.
• Safety Documentation Authoring: Take principal accountability for drafting, maintaining, and obtaining approval for all formal clinical safety documentation, including the Clinical Risk Management Plan (CRMP) and the final Clinical Safety Case Report (CSCR), ensuring consistency with evidence within the CRMF.

Regulatory Compliance and Vigilance (MHRA SaMD)

• Technical File Contribution: Ensure the clinical risk management evidence (RMF and CSCR) contributed to the SaMD Technical File complies with both DCB 0129 and the international risk management standard ISO 14971, as mandated by the UK Medical Device Regulations.
• Clinical Evaluation Support: Provide expert clinical insight and input into the Clinical Evaluation Plan and Clinical Evaluation Report (CER), focusing on validating the clinical association, performance, and safety of the Class IIa device for its intended purpose.
• Post-Market Surveillance (PMS) Management: Develop, implement, and oversee the clinical aspects of the PMS Plan, including continuous monitoring and systematic review of the risk acceptability of the product once it is in use.
• Incident and Vigilance Reporting: Manage the entire process for reporting serious adverse incidents involving the SaMD product to the MHRA and European regulators via the MORE / EUDaMED portal (Vigilance system), ensuring timely compliance with regulatory reporting criteria and deadlines.
• Root Cause Analysis: Lead specialised clinical safety investigations (e.g., using RCA/SEIPS methodology) into reported incidents, particularly those resulting in potential indirect patient harm (such as delayed treatment or misdiagnosis), and ensure that resulting Corrective and Preventative Actions (CAPAs) are defined and implemented to update the Hazard Log.

Governance, Audit, and Training

• Internal Governance: Align and manage the organization's digital clinical risk management policies, ensuring all processes and guidance are formally updated, ratified by governance bodies, and effectively cascaded to appropriate stakeholders.
• Audit Readiness: Coordinate and support internal safety audits (utilizing DCB 0129 compliance checklists) and supplier audits to assess and assure continuous adherence to the CRMS, maintaining audit-readiness for UK Approved Bodies.
• Clinical Expertise Maintenance: Actively seek out and integrate knowledge on national healthcare safety issues, clinical best practices, and emerging digital health trends to ensure the application of a current and authoritative 'clinical lens' to risk management.