Medical Devices Safety Officer

NHS; Liverpool; On-site; GBP 70,000 - 90,000; Full time

Job summary

The Walton Centre NHS Foundation Trust is seeking a Medical Devices Safety Officer (MDSO) to provide trust-wide leadership, assurance and oversight of medical device safety, governance and regulatory compliance. The postholder ensures devices are managed safely through their lifecycle and meet MHRA, NHS England and CQC requirements.

They will lead responses to alerts/recalls, coordinate investigations, support audits and training, and liaise with EBME, procurement, estates and regulators.

Qualifications

• Experience in healthcare governance, risk management or patient safety.
• CPD ongoing and evidence of professional development.

Responsibilities

• Provide trust-wide leadership on medical device safety, governance and regulatory compliance.
• Lead the management of medical device alerts, recalls and Field Safety Notices (FSNs).
• Coordinate investigations into device-related incidents and ensure organisational learning.
• Develop and maintain policies and governance arrangements for medical device management.
• Monitor training and competency arrangements for medical devices and support clinician training.
• Support internal and external inspections, audits and regulatory reviews.

Skills

Confident communicator

Leadership

Education

Degree level qualification

Postgraduate qualification in Risk Management

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.

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.

Working for our organisation

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.

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.

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.

Person specification

Qualifications

• Degree level qualification in a relevant subject (e.g. healthcare, clinical governance, risk management, engineering, quality or patient safety) or equivalent level knowledge and experience gained through professional practice.
• Evidence of ongoing Continuing Professional Development (CPD).
• Specialist knowledge of medical device governance, risk management and regulatory compliance acquired through experience, professional development or further study.
• Postgraduate qualification in Risk Management, Governance, Patient Safety, Healthcare Management, Medical Device Management or related field.
• Recognised Health and Safety qualification.
• Membership of a relevant professional body.

Knowledge & Experience

• Experience of governance, risk management, patient safety or medical device management within a complex healthcare organisation.
• Experience of providing specialist advice to senior managers, clinicians and governance committees.
• Experience of leading investigations, implementing recommendations and monitoring organisational learning.
• Experience of developing, implementing and monitoring policies, procedures and assurance frameworks.
• Awareness of budget management for medical devices
• Understanding of medical device training frameworks.
• Experience as a Medical Devices Safety Officer (MDSO).
• Experience leading medical device-related investigations.
• Involvement in clinical audit and quality improvement projects.

Other

• Confident communicator, capable of liaising at a technical level with external consultants and non-technical internal clients/customers
• Able to lead by providing a good example and practice

Employer certification / accreditation badges

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.