Clinical Safety Lead for SaMD & Health IT (Hybrid/Remote) in Sheffield

The purpose of the Clinical Safety Officer role is to provide oversight and expert leadership on all matters relating to the clinical safety of digital systems across the organisation. The postholder will ensure compliance with DCB 0129 and relevant regulatory requirements, including those relating to Software as a Medical Device (SaMD), by identifying and managing clinical risk, advising on safety implications, and supporting effective governance arrangements. The role exists to safeguard patients and service users, promote best practice in clinical risk management, and ensure the organisation meets its clinical safety, statutory, and regulatory obligations throughout the system lifecycle.

Location: Hybrid / Remote

Hours: 16 hours per week with flexibility to agree specific working patterns.

About Preventx: Preventx is a fast-growing technology company with more than 13 years’ experience as the market leader in online sexual health and STI sampling services. We work with over 60 local authority regions and NHS providers across the UK and are a trusted partner of the NHS. Our services have enabled around 1.7m people to test for STIs, improving public health whilst saving money. With recent investment, the company is committed to growth and continuous improvement. You will join a supportive team where you’ll be encouraged to do your best work and define the way we use data in the business.

Job Summary: The Clinical Safety Officer is responsible for ensuring the clinical safety of digital systems used within the organisation, with a primary focus on DCB 0129 compliance and Software as a Medical Device (SaMD) regulatory obligation. The post holder will provide clinical safety leadership across the full system lifecycle, ensuring that clinical risks associated with digital systems are identified, assessed, managed, and monitored effectively. The CSO will play a key role in incident review, system change assessment and supporting safe innovation.

Key Responsibilities

• Act as the named Clinical Safety Officer in accordance with DCB 0129 requirements.
• Lead and maintain the Clinical Safety Management System (CSMS).
• Ensure clinical risks are proactively identified, assessed, mitigated, and recorded throughout the system lifecycle.
• Provide expert clinical safety advice to product, engineering, operational, and leadership teams.

DCB 0129 Compliance

• Lead organisational compliance with DCB 0129 (Clinical Risk Management: its Application in the Manufacture of Health IT Systems).
• Produce, maintain, and approve key artefacts including Clinical Safety Case Reports (CSCRs), Hazard Logs, Safety Plans and Safety Arguments, and prepare organisations and products for audits, assurance, and external scrutiny.

Software as a Medical Device (SaMD)

• Support and oversee SaMD regulatory compliance, including UK MDR and MHRA expectations where applicable.
• Work with regulatory, quality, and product teams to ensure clinical safety evidence supports SaMD registration and ongoing conformity.
• Contribute clinical safety input into product classification, intended use statements, and post‑market surveillance activities.
• Support the development, implementation, and continual improvement of an ISO 13485–compliant Quality Management System, ensuring clinical safety processes are appropriately integrated with design controls, risk management, and post‑market activities.

Incident Management & Learning

• Review and assess clinical safety incidents, near misses, and safety concerns.
• Lead or contribute to root cause analyses and safety investigations.
• Ensure learning from incidents is translated into system improvements and risk mitigation actions.
• Liaise with internal governance structures and external bodies where required.

Change & Impact Assessment

• Review proposed and actual system changes for clinical safety impact.
• Provide formal clinical safety sign‑off for system enhancements, configuration changes, deployments and upgrades.
• Ensure change control processes adequately address clinical risk.

Stakeholder Engagement & Leadership

• Work collaboratively with clinicians, developers, testers, product owners, and operational teams.
• Communicate clinical safety risks clearly to both technical and non‑technical stakeholders.
• Promote a strong culture of clinical safety across the organisation.
• Support training and awareness activities relating to clinical risk management.

Qualifications

• Current registration with a relevant professional body.
• Proven experience delivering clinical risk management for health IT systems.
• Demonstrable working knowledge of DCB 0129 and the ability to act as Clinical Safety Officer.
• Working knowledge or a sound understanding of UK MDR and MHRA expectations for SaMD.
• Strong analytical and problem‑solving skills, with the ability to interpret complex legislation and apply it in a practical, proportionate way.
• Excellent written and verbal communication skills, capable of providing clear guidance to technical and non‑technical audiences.
• Ability to work independently and act impartially, exercising sound judgement in high‑stakes or time‑sensitive situations.
• Experience reviewing and managing clinical safety incidents, near misses, and safety concerns.
• High attention to detail with strong organisational and record‑keeping skills.

This job description is not exhaustive and serves only to highlight the main requirements of the post holder. The line manager may stipulate other reasonable requirements. The job description will be reviewed regularly and may be subject to change.

Equity, Diversity & Inclusion

At Preventx, we believe diversity drives innovation and inclusion strengthens our impact. We’re committed to creating a workplace that values individual differences and fosters a culture of respect, belonging, and growth. We welcome applications from people of all backgrounds, identities, and experiences—including those from underrepresented communities. If you need any support with your application or adjustments during the recruitment process, we’re here to help.