Senior Risk Management Engineer, Medical Devices (ISO 14971/ IEC 60601/IEC 62304)
Vision RT is a rapidly growing MedTech transforming radiation therapy for cancer patients. With around 300 employees globally, we are the inventors and market leaders in Surface Guided Radiation Therapy (SGRT), used in 24 of the 25 “Best Hospitals for Cancer.” We operate under the Danish company William Demant Invest A/S.
About the role: You will sit with the compliance team, creating and maintaining Risk Management files for Vision RT 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;
* Develop Risk Traceability Matrices and conduct 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, assigning severity scores and ensuring timely risk mitigation strategies are in place;
* Conduct in‑depth risk reviews of post‑market surveillance data, including complaints, field performance, and 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:
* 5+ years of risk management experience in regulated Class II or III medical device environments;
* Deep knowledge of ISO 14971, ISO/TR 24971, IEC 62304, and ideally IEC 60601;
* Experience in post‑market risk analysis, trend analysis, and risk re‑evaluation based on real‑world data;
* Proficiency with ALM tools such as Polarion, MatrixALM, DOORS, or Enterprise Architect;
* Strong analytical and organizational skills, with the ability to manage multiple priorities and deadlines;
* Excellent communication skills, able 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.
* Additional familiarity with IEC 62366‑1, IEC 60601‑1‑2, and experience in Agile development environments;
* Prior involvement in regulatory inspections or audits (e.g., FDA, Notified Bodies).
Seniority Level
Mid‑Senior level
Employment Type
Full‑time
Job Function
Engineering, Manufacturing, and Quality Assurance
Industries
Medical Equipment Manufacturing
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