Job Description
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
1. 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
2. Conduct risk assessments for design changes and define appropriate risk controls.
3. Collaborate with systems, software, and hardware teams to define and review risk control measures.
4. Lead anomaly review boards, assign severity scores, and ensure timely mitigation strategies.
5. Analyse post-market surve...