Medical Devices Safety Officer

Walton Centre NHS Foundation Trust; Liverpool; On-site; GBP 65,000 - 80,000; Full time

Job summary

The Walton Centre NHS Foundation Trust is seeking a Medical Devices Safety Officer to provide Trust-wide leadership for the safe management and governance of medical devices. You will oversee alerts, recalls and FSNs, coordinate investigations and ensure regulatory compliance across the organisation to support safe, high-quality patient care.

You will collaborate with EBME, procurement, estates and governance teams to monitor device risks, provide expert advice to staff and senior leaders, and

Qualifications

• Expert guidance on medical device governance and regulatory compliance.
• Ability to identify and monitor medical device risks and learning opportunities.
• Experience coordinating audits and training related to device management.

Responsibilities

• 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.

Job description

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.,

• 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 Walton Centre NHS Foundation Trust is the only NHS trust to hold dual accreditation for the Investors in People. We invest in people and we invest in wellbeing standards and have been awarded Gold status for both. The Walton Centre is a leader in the treatment and care of neurology and neurosurgery, placing the patient and their family at the heart of everything we do. As the only specialist hospital trust in the UK dedicated to providing comprehensive neurology, neurosurgery, spinal and pain management services we are proud to be rated as an Outstanding Trust by the Care Quality Commission (CQC), and champion change throughout the field of neuroscience. Originally formed in 1992, the Trust received Foundation Trust status in 2009.

With around 1,450 staff, The Walton Centre treats more than 127,000 outpatients and 18,000 inpatients each year. We have leading specialists and incredibly dedicated staff delivering excellent clinical outcomes for brain, spinal and neurological care nationally and internationally. Teams across our site in Fazakerley, Liverpool, offer a world-class service in diagnosing and treating injuries and illnesses affecting the brain, spine and peripheral nerves and muscles, and in supporting people suffering from a wide range of long-term neurological conditions.