Senior Risk Management Engineer, Medical Devices (ISO 14971/ IEC 60601/IEC 62304)
Rapidly growing MedTech transforming radiation therapy for cancer patients, helping to make it more accurate, effective and comfortable. Technology that uses advanced 3D cameras to track surface data, for more guidance across every step of the radiotherapy workflow.
With around 300 employees globally, and offices in the UK, Poland & the USA, staff members enjoy the security and reach of a large global enterprise combined with the agility of a startup.
This role sits with the compliance team and involves creating and maintaining Risk Management files for medical devices, including pre and post‑market risk analysis in an agile landscape.
Key Responsibilities
* Lead the creation, maintenance and continuous improvement of comprehensive Risk Management Files in accordance with ISO 14971, including risk traceability matrices, change control and anomaly risk reviews.
* Drive risk assessments for design changes, ensuring appropriate risk controls are identified and implemented.
* Define and review risk control measures as design inputs, collaborating closely with systems, software and hardware teams.
* Lead anomaly review boards, assign severity scores and ensure timely risk mitigation strategies are in place.
* Conduct in‑depth risk reviews of post‑market surveillance data (complaints, field performance, adverse event reports) to identify trends and initiate corrective actions.
* Support regulatory submissions and audits by ensuring risk documentation is inspection‑ready and aligned with global regulatory expectations.
* Contribute to the development and refinement of internal risk management processes and tools.
* Occasional UK and international travel may be required.
Qualifications
* Proven experience (typically 5+ years) in risk management for medical devices, ideally in a regulated Class II or III environment.
* Deep, practical knowledge of ISO 14971 and ISO/TR 24971, with a track record of applying these standards across the product lifecycle.
* Strong understanding of IEC 62304 (software lifecycle) and ideally IEC 60601 (electrical safety).
* Experience in post‑market risk analysis, including trend analysis and risk re‑evaluation based on real‑world data.
* Proficiency with application lifecycle management tools such as Polarion, MatrixALM, DOORS or Enterprise Architect.
* Experience working in Agile development environments.
* Prior involvement in regulatory inspections or audits (e.g., FDA, Notified Bodies).
* Strong analytical and organizational skills, with the ability to manage multiple priorities and deadlines.
* Excellent communication skills, including the ability to present complex risk concepts to cross‑functional teams and senior stakeholders.
* Comfortable working in a global, cross‑functional environment, with a collaborative and proactive mindset.
* Proficient in Microsoft Office tools (Word, Excel, PowerPoint, Outlook).
* Fluent in written and spoken English.
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