Remote Senior Risk Management Engineer, Medical Devices (ISO 14971/ IEC 60601/IEC 62304) 12 mon[...]

Vision RT Vision RT is a rapidly growing MedTech company transforming radiation therapy for cancer patients, making it more accurate, effective, and comfortable. We are the inventors and market leaders in Surface Guided Radiation Therapy (SGRT), utilizing advanced 3D cameras for surface data tracking throughout radiotherapy workflows. Our SGRT solutions are used in 24 of the 25 “Best Hospitals for Cancer,” according to US News & World Report. Recognized as one of Britain’s fastest-growing private tech companies, we were listed in the 2025 Sunday Times 100 Tech and are proud winners of the 2024 King’s Award for Enterprise . With around 300 employees globally and offices in the UK, Poland, and the USA, Vision RT operates as part of William Demant Invest A/S, a major global healthcare investor. We offer a unique blend of stability and agility, driven by strong values, a clear mission, and a promising future. About the Role: We are seeking a dedicated Senior Risk Management Specialist to join our Compliance team. You will be responsible for creating and maintaining Risk Management Files for Vision RT medical devices , including conducting comprehensive pre- and post-market risk analyses in an agile environment. This role offers remote flexibility based on experience. Candidates meeting all skill requirements may work remotely with an expectation of 2-3 days per month at our London or Basingstoke office , especially during the initial contract phase. For those needing skill development, a hybrid work model is available, requiring regular in-office collaboration in London or Basingstoke for learning and development support. Assist in creating and maintaining Risk Management files for Vision RT medical devices, including: Risk Management Plans, Risk Hazard Analysis, Risk Register, Risk-benefit Analysis, Risk-traceability Analysis, Anomalies/Change Control Review, and Risk Management Reports. Participate in risk reviews for proposed design changes. Create risk control requirements as inputs to product design. Participate in anomaly review meetings to assess and assign severity scores to known product anomalies. Conduct risk reviews of post-market surveillance data. Support the company’s quality policy and objectives with other related duties. Occasional UK and international travel may be required. Minimum Requirements: Extensive commercial experience in risk management for medical devices. Deep knowledge of ISO 14971 and ISO/TR 24971 standards. Familiarity with IEC 62304 and ideally IEC 60601 standards. Working knowledge of application lifecycle management tools used in medical device development. Strong organizational skills with the ability to prioritize tasks effectively. Excellent communication, writing, and presentation skills. Ability to interact professionally across various organizational levels. Proficiency in Microsoft Word, Excel, PowerPoint, Outlook, and general computer skills. Fluent in written and spoken English. Knowledge of IEC 62366-1, IEC 62368-1, IEC 60601-1-2 standards. Experience with development tools like Polarion, MatrixALM, DOORS, etc. Experience working in an agile environment. Vision RT is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration regardless of race, color, religion, sexual orientation, gender, national origin, disability, or protected veteran status. #J-18808-Ljbffr