Clinical Safety Officer (Medtech) | Contract | Leeds

We’re recruiting a Clinical Safety Officer for a contract role with a digital health and medtech company. As the named clinical safety lead, you’ll provide clinical risk management oversight for health software used across the UK health and care system, in line with DCB0129 and DCB0160.Location: Leeds, UKDay rate: £550–£650 per day (IR35 status to be confirmed)Contract: Initial 6–12 months, likely extension

What you’ll do:

• Act as named CSO, accountable for clinical risk management under DCB0129 and DCB0160
• Own the Clinical Risk Management Plan, Hazard Log and Clinical Safety Case Report for each release
• Lead hazard identification workshops with product, engineering, QA and clinical teams
• Review releases and design changes for clinical safety impact
• Support NHS customer assurance, including trust due diligence and DTAC submissions
• Manage clinical safety incidents and post-market feedback

What you’ll bring:

• Current UK clinical registration (GMC, NMC, HCPC, GPhC) in good standing
• Accredited CSO training for DCB0129/DCB0160
• 3–5 years’ clinical safety, clinical risk management or health informatics experience
• Proven experience producing Hazard Logs and Clinical Safety Case Reports
• Working knowledge of ISO 14971 and MHRA requirements for software as a medical device
• Right to work in the UK

Desirable: AI/ML-enabled devices, EPR integrations, DTAC/DSPT experience, IEC 62304, IEC 62366, ISO 13485.

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