Clinical Safety Officer - #2168953

Clinical Safety Officer (CSO)

Employed or contract | Remote first, UK based, with occasional travel to client sites

About DigiSafe

DigiSafe Compliance Ltd supports health and care organisations, IT manufacturers and digital health innovators meet the mandated clinical safety standards DCB0129 and DCB0160, wider DTAC and MHRA regulations.

Our team brings together clinical safety, digital health and AI expertise. We work alongside our clients to build safety, assurance and governance into how they work every day, so that their digital products are safe, effective, compliant and designed around patients.

Our work covers:

• Clinical safety and governance frameworks
• AI safety and assurance assessments
• DTAC compliance
• Medical device qualification and classification
• Digital transformation programmes

The role

Demand for our services keeps growing, so we are looking for experienced Clinical Safety Officers to join us on either an employed or a contract basis. You’ll support a busy portfolio of national, regional and local digital health projects. The role is remote first, and some projects may ask for occasional on site attendance, depending on the client.

As a CSO, you will lead clinical risk management across digital health systems, from early design through deployment and live use. You will work with our team, clients, suppliers and clinical stakeholders to make sure clinical risk is found, controlled and clearly evidenced.

Key responsibilities

• Act as named Clinical Safety Officer for digital health and care systems, products and services
• Set up and run clinical risk management systems in line with DCB0129 and DCB0160
• Plan and lead hazard identification workshops with clinical, technical and operational teams
• Write, review and maintain Clinical Risk Management Plans, hazard logs and Clinical Safety Case Reports
• Assess the clinical safety impact of changes, releases, integrations and incidents
• Support incident investigations, including root cause analysis and corrective actions
• Advise project teams, suppliers and clients on clinical safety, including for AI enabled tools and medical devices
• Deliver clinical safety training and awareness sessions where required
• Contribute to governance, assurance and DTAC activity across projects
• Work independently while staying connected to the wider DigiSafe team and our quality checks

Essential

• Registered healthcare professional with a current registration (for example NMC, GMC, GPhC or HCPC)
• Completed clinical risk management or CSO training, with certificate
• At least 2 years’ experience working as a CSO under both DCB0129 and DCB0160
• A track record of producing hazard logs and safety cases that have been signed off
• Confident running workshops and explaining clinical risk clearly to clinical and non clinical audiences
• Able to manage your own workload remotely across more than one client

Desirable

• Experience on national programmes, EPR deployments or shared care records
• Working knowledge of DTAC v2.0, UK MDR and the EU MDR
• Previous consultancy or multi client experience
• Experience of medical devices or Software as a Medical Device, including qualification, classification or ISO 14971 risk management
• Experience of AI enabled or data driven health technology, such as ambient voice, decision support or analytics

What we offer

• A choice of employed or contract working
• Remote first working, with occasional hybrid opportunities
• Meaningful work on digital health and patient safety projects across the NHS and industry
• Variety, from AI and medical devices to national programmes
• A supportive team with peer review, shared templates and regular team calls
• Ongoing development through our CPD certified CSO Training Academy

How to apply

Please send the following to [email protected] by 31st October:

• your CV
• whether you are interested in an employed role, a contract role, or both
• your salary expectations (for an employed role) and/or your day rate (for a contract role)
• a short note on your relevant experience, including:
• DCB0129 and DCB0160
• whether that work was at local, regional or national level any medical device and AI work