Medical Devices Safety Officer

Job overview

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.

The role will oversee the management of medical device safety alerts, recalls and Field Safety Notices (FSNs), monitor compliance with medical device regulations, coordinate investigations into device-related incidents and ensure organisational learning is identified and implemented. The postholder will work closely with clinical teams, EBME, procurement, estates and governance colleagues to ensure medical devices are appropriately maintained, monitored and managed throughout their lifecycle

The postholder will provide expert advice to staff and senior leaders on medical device governance, maintain oversight of medical device-related risks and deliver assurance reporting through the Trust's governance framework, including the Medical Devices Group. They will also support medical device audits, monitor training and competency compliance and act as the key liaison with external regulators, manufacturers and national safety networks.

Main duties of the job

• 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.

Detailed job description and main responsibilities

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.

Main Duties and Responsibilities

Medical Device Safety and Compliance

• Act as the Trust's designated Medical Devices Safety Officer (MDSO).
• Lead the Trust response to Medical Device Alerts, Field Safety Notices (FSNs), recalls and safety communications.
• Ensure compliance with MHRA, NHS England and CQC requirements relating to medical devices. [Medical de...ty officer | Word]
• Provide specialist advice and support on medical device management and safety. [Medical de...ty officer | Word]

Risk Management and Incident Investigation

• Maintain oversight of medical device-related risks and ensure effective risk assessment, escalation and monitoring.
• Oversee the reporting, investigation and learning from medical device-related incidents.
• Identify themes and trends from incidents and implement actions to improve patient safety and reduce risk.
• Liaise with national bodies and manufacturers regarding significant safety concerns and incidents.

Governance and Assurance

• Coordinate the Medical Devices Group and provide regular assurance reports to Trust governance committees.
• Develop, implement and review policies, procedures and guidance relating to medical device management.
• Monitor compliance with medical device governance arrangements and recommend improvements where necessary.
• Support internal and external inspections, audits and regulatory reviews.

Audit, Monitoring and Improvement

• Lead and coordinate audits relating to medical device safety, maintenance, storage and governance arrangements.
• Monitor compliance with action plans arising from audits, inspections and investigations
• Promote continuous improvement and organisational learning across the Trust.

Training and Competency

• Ensure appropriate training and competency frameworks are in place for the safe use of medical devices.
• Monitor compliance with training requirements and provide assurance regarding staff competency.
• Work with Clinical Educators and service leads to support the development of medical device training programmes.

Partnership Working

• Work collaboratively with clinical teams, EBME, procurement, estates and support services to ensure effective medical device management
• Act as the Trust's key contact with the MHRA, NHS England, medical device manufacturers and external stakeholders.
• Represent the Trust at regional and national Medical Devices Safety Officer networks and forums.

Reporting and Assurance

• Produce regular reports on compliance, incidents, risks, training and safety alerts for the Medical Devices Group and relevant committees.
• Provide assurance to the Trust Board and senior leadership that medical devices are managed safely and in accordance with national requirements

This role is pivotal in ensuring that medical devices are used safely, regulatory requirements are met, risks are effectively managed, and patients receive safe, high-quality care.

Applicant requirements

The postholder will have access to vulnerable people in the course of their normal duties and as such this post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service to check for any previous criminal convictions.