Risk Management Specialist - ISO 14971 & ISO/TR 24971
North London, Basingstoke or Warsaw
Finance & Ops – Quality Systems & Complaints /
Permanent, Full-time /
Hybrid
Vision RT is a rapidly expanding MedTech company at the forefront of transforming radiation therapy. We are the inventors of Surface Guided Radiation Therapy (SGRT), which harnesses advanced 3D camera systems and sophisticated AI, Computer Vision, and Machine Learning software. Our mission is to enhance the safety, precision, and comfort of radiation therapy for patients. Notably, our innovative solutions are deployed across all 15 of the prestigious "Best Hospitals for Cancer," as recognized by US News & World Report
With around 300 employees globally, and offices in the UK, Poland & US, we operate autonomously as part of the Danish company Demant A/S, one of the largest healthcare companies in the world.
About the role:
This role sits with the compliance team and involves creating and maintaining Risk Management files for Vision RT medical devices, including FMEA scoring systems, risk management plans, and various pre and post-market risk analysis reports.
Key Responsibilities will include:
- Assist in the creation and maintenance of Risk Management files for Vision RT medical devices per, including: Failure mode effects analysis scoring system, Risk management plans, Preliminary hazard analysis reports, Risk hazard analysis reports, Register of risks (DFMEA), Risk-benefit analysis, Risk-traceability analysis, Anomalies review reports 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 consider and assign severity scores to known product anomalies.
- Conduct risk reviews of post-market surveillance data.
- Other duties in support of the company’s quality policy and objectives.
- This role requires occasional UK and international travel.
Essential Skills & Experience
- Minimum 3 years’ commercial experience in risk management for medical devices or a related field.
- Extensive knowledge of ISO 14971 and ISO/TR 24971.
- Working knowledge of application lifecycle management tools used in medical device development.
- Strong organizational skills, and ability to triage and prioritise tasks.
- Excellent verbal communication, writing and presentation skills.
- Ability to work and interact effectively and professionally with others throughout various levels of the global organization.
- Competent in Microsoft Word, Excel, PowerPoint, Outlook and general computer usage.
- Fluent in written and spoken English.
Desirable Skills & Experience
- Working knowledge of IEC 62304, IEC 62366-1, IEC 62368-1, IEC 60601-1, IEC 60601-1-2.
- Experience of risk management of active medical devices containing software.
Vision RT is an Equal Opportunity / Affirmative Action employer, all qualified applicants will receive consideration for employment and development without regard to race, colour, religion, sexual orientation, gender, national origin, disability, or protected veteran status.
