Medical Devices Safety Officer

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.