About the role
Salary: £49387.00 to £56515.00
The Medical Devices Safety Officer (MDSO) will provide Trust-wide leadership, oversight and assurance in relation to the safe management, governance and regulatory compliance of medical devices across The Walton Centre NHS Foundation Trust. The postholder will act as the Trust's designated lead for medical device safety, ensuring compliance with MHRA, NHS England and CQC requirements and supporting the organisation to deliver safe, effective and high-quality patient care.
Lead the management and coordination of Medical Device Alerts, recalls and Field Safety Notices (FSNs), ensuring timely implementation and monitoring of actions.
Ensure compliance with MHRA, NHS England and CQC requirements relating to the safe management and use of medical devices
Maintain oversight of medical device-related risks and ensure risks are appropriately assessed, escalated and monitored
Lead and support the investigation of medical device-related incidents, ensuring learning opportunities are identified and improvements implemented
Monitor trends in incidents, maintenance issues and compliance concerns, escalating significant risks as required.
Coordinate the Medical Devices Group and provide regular assurance reports on compliance, incidents, training and emerging risks.
Develop and maintain policies, procedures and governance arrangements relating to medical device management.
Lead and support audits of medical device management arrangements, monitoring action plans and compliance improvements.
Prepare reports and assurance documentation for Trust committees and senior management as required.
Work with clinical and operational teams to ensure appropriate training and competency arrangements are in place for medical devices.
Monitor compliance with medical device training requirements and provide assurance regarding staff competency.
Support the development and implementation of competency frameworks for high-risk medical devices.
The Medical Devices Safety Officer (MDSO) is responsible for providing Trust-wide leadership, assurance and oversight of medical device safety, governance and regulatory compliance. The postholder will ensure that medical devices are managed safely and effectively throughout their lifecycle and that the Trust meets all relevant requirements set by the MHRA, NHS England and the Care Quality Commission (CQC). The role provides expert advice on medical device governance, supports organisational learning from incidents, and ensures robust systems are in place for the management of safety alerts, recalls, maintenance, training and competency assurance. The postholder will work collaboratively with clinical services, EBME, procurement, estates and external organisations to promote patient safety and regulatory compliance across the Trust.