Medical Devices Safety Officer

Job Overview

An exciting opportunity has arisen for an experienced and motivated professional to join the CNWL Safety Team as a Medical Devices Safety Officer (MDSO) on a 12-month fixed-term maternity cover contract.

Please note: This vacancy does not meet the criteria for Skilled Worker sponsorship, unless you meet the criteria by temporary exemption from current changes to immigration rules put in force on 22/07/2025. “Separate provisions are applied to workers who have been sponsored and held continuously Skilled Worker visa since prior to 04/04/2024."

As such, if you don’t meet the Transitional Provision (above) we are unable to consider your application unless you can provide documentary evidence of your right to work in the United Kingdom. If you believe you are eligible for sponsorship or already hold a valid right to work in the UK, please ensure you provide full details of your immigration status in the Pre-Screening Immigration section of your application form.

Please note role eligibility also depends on whether the role meets the salary threshold for the relevant occupational code (SOC CODE).

For further info please visit: Skilled Worker visa: Overview - GOV.UK

Main duties of the job

This is an excellent opportunity to play a key role in improving patient safety by leading the Trust's medical device safety programme. You will work collaboratively with clinical teams, Procurement and Governance colleagues to ensure the safe management, introduction and use of medical devices across the organisation. As the Trust's Medical Devices Safety Officer, you will ensure compliance with MHRA requirements, investigate device-related incidents, monitor and report on compliance with medical device safety standards.

The MDSO is a key role in promoting and improving the safe use of medical devices in the Trust, including contract management and monitoring. This role provides a link on Medical Device Safety for MHRA, NHS England and device manufacturers concerning identified safety issues.

Working for our organisation

In addition to improving the quality of reporting, the MDSO would serve as the essential link between the identification and implementation of medical device safety initiatives and the daily operations to improve the safe use of medical devices.

This fixed-term role offers the opportunity to contribute to a high-performing patient safety team while gaining valuable experience in medical device governance within a large NHS Trust.

Detailed Job Description And Main Responsibilities

• Lead the Trust-wide medical devices management ensuring compliance with the Medicines and Healthcare products Regulatory Agency (MHRA) Managing Medical Devices framework, including systems for acquisition, deployment, maintenance, training, decontamination and medical devices budget management and capital spend budget management.
• Act as the named Medical Devices Safety Officer (MDSO) for CNWL, ensuring responsibilities align with NHS England enduring standards for provider organisations.
• Chair the Medical Devices Maintenance contract and Glucometers Contract meetings, providing expert advice, assurance, and governance updates to relevant committees, including escalation to the Assistant Director of Safety where required.
• Maintain alignment with CNWL’s risk, assurance, procurement, maintenance, incident reporting, and infection prevention frameworks, ensuring robust governance arrangements across all services.
• Lead investigations of all serious medical device-related incidents, ensuring high-quality reporting, learning, and continuous improvement across the Trust.
• Ensure all incidents are reported to the MHRA via the Yellow Card system and that national safety notices are actioned within required timeframes.
• Provide regular reports on device-related incidents, safety themes, and risks to governance committees and the Medical Devices Corporate meetings.
• Ensure Trust-wide compliance with NHS England safety standards, including maintaining the Medical Devices Safety Officer (MDSO) function, promoting staff competency, and assuring safe procurement and maintenance arrangements.
• Lead the implementation and monitoring of responses to safety alerts issued by the Medicines and Healthcare products Regulatory Agency (MHRA) and manufacturers, including Field Safety Notices (FSNs) and device recalls, ensuring timely and effective completion of required actions.
• Lead and oversee a Trust-wide programme of medical devices audits, developing and implementing a sustainable and repeatable audit framework to ensure compliance with internal policies, regulatory standards, and best practice.
• Provide oversight and assurance of audit outcomes, identifying trends, risks, and areas for improvement, ensuring findings are translated into clear action plans that are monitored, delivered, and escalated as required.
• Ensure robust systems are in place to manage the full lifecycle of medical devices, including procurement, acceptance testing, maintenance, repair, decontamination, and disposal, in line with MHRA guidance.
• Oversee the accuracy and governance of the Trust’s medical devices inventory and support quality standards and accreditation of relevant services.
• Provide specialist input into procurement processes, including evaluation and approval of new medical devices in collaboration with Procurement and clinical teams.
• Ensure effective systems are in place for staff training and competency assessment in the use of medical devices, in line with MHRA requirements. This will be done via the Medical Devices Passport documents.
• Provide expert advice and support to clinical and managerial staff on safe device use, risk management, and best practice.
• Ensure strong financial governance through budget setting, forecasting, reporting, and risk management, while driving cost improvement, standardisation, and value for money.
• Lead strategic procurement and contract management for high-value services and work in partnership with Finance, Procurement, Estates, and clinical teams to align asset management with wider organisational strategies, providing assurance to Executive-level committees on financial performance and capital delivery.
• Lead the strategic management and tendering of contracts for medical devices maintenance providers, including the Trust-wide glucometer service, ensuring performance, compliance, and value for money.
• Chair medical devices and glucometer contract meetings, providing oversight, challenge, and assurance on supplier performance.
• Oversee procurement and contract processes, monitor performance against KPIs and SLAs, and take action to address risks or underperformance.
• Drive standardisation and continuous improvement to deliver safe, high-quality, and cost-effective services, ensuring compliance with Trust policies and Medicines and Healthcare products Regulatory Agency (MHRA) requirements, and provide assurance reporting to senior governance forums.