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.

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.

• 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.

• 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.

• 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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