A leading medical technology company is seeking a Senior Risk Management Engineer to join the business in a hybrid role which can be at their London or Hampshire site. This organisation develops advanced imaging and guidance systems used in radiation therapy, with a strong global presence and a reputation for innovation and excellence in patient care.

About the Role

This position involves the creation and maintenance of comprehensive Risk Management Files for medical devices, covering both pre- and post-market risk analysis in a fast-paced, agile environment. You will play a key role in ensuring product safety and regulatory compliance throughout the device lifecycle.

Key Responsibilities

Lead the development and continuous improvement of Risk Management Files in accordance with ISO 14971, including:

Risk Management Plans Hazard Analyses Risk Registers Benefit-Risk Analyses Risk Traceability Matrices Change Control and Anomaly Risk Reviews Final Risk Management Reports

Conduct risk assessments for design changes and define appropriate risk controls. Collaborate with systems, software, and hardware teams to define and review risk control measures. Lead anomaly review boards, assign severity scores, and ensure timely mitigation strategies. Analyse post-market surveillance data (e.g., complaints, field performance, adverse events) to identify trends and initiate corrective actions. Support regulatory submissions and audits by ensuring risk documentation is inspection-ready. Contribute to the development of internal risk management processes and tools. Occasional UK and international travel may be required.

Essential Skills & Experience

5+ years of experience in risk management for medical devices, ideally in a regulated Class II or III environment. Deep knowledge of ISO 14971 and ISO/TR 24971, with practical application across the product lifecycle. Strong understanding of IEC 62304 (software lifecycle) and ideally IEC 60601 (electrical safety). Experience in post-market risk analysis and trend evaluation using real-world data. Strong analytical, organisational, and communication skills. Comfortable working in a global, cross-functional environment. Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook). Fluent in written and spoken English.

Desirable Skills & Experience

Familiarity with IEC 62366-1 (Usability Engineering) and IEC 60601-1-2 (EMC). Experience in Agile development environments. Prior involvement in regulatory inspections or audits (e.g., FDA, Notified Bodies). Proficiency with ALM tools such as Polarion, MatrixALM, DOORS, or Enterprise Architect.

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