About the role:
This role sits with the compliance team and involves creating and maintaining Risk Management files for Vision RT medical devices, including pre and post-market risk analysis in an agile landscape.
As a Senior Risk Management Engineer at Vision RT, you will play a critical role in ensuring the safety and compliance of our medical devices throughout their lifecycle.
Key Responsibilities will include:
- Leading the creation, maintenance, and continuous improvement of comprehensive Risk Management Files in accordance with ISO 14971, including:
- Risk Management Plans
- Hazard Analyses
- Risk Registers
- Benefit-risk Analysis
- Risk Traceability Matrices
- Change Control and Anomaly Risk Reviews
- Final Risk Management Reports
- Driving risk assessments for design changes, ensuring appropriate risk controls are identified and implemented.
- Defining and reviewing risk control measures as design inputs, collaborating closely with systems, software, and hardware teams.
- Leading anomaly review boards, assigning severity scores, and ensuring timely risk mitigation strategies are in place.
- Conducting in-depth risk reviews of post-market surveillance data, including complaints, field performance, and adverse event reports, to identify trends and initiate corrective actions.
- Supporting regulatory submissions and audits by ensuring risk documentation is inspection-ready and aligned with global regulatory expectations.
- Contributing to the development and refinement of internal risk management processes and tools.
- Occasional UK and international travel may be required.
Essential Skills & Experience
- 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).
- Demonstrated experience in post-market risk analysis, including trend analysis and risk re-evaluation based on real-world data.
- Proficiency with application lifecycle management (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, 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.
Desirable Skills & Experience
- Familiarity with additional standards such as: IEC 62366-1 (Usability Engineering) & IEC 60601-1-2 (EMC)
- Experience working in Agile development environments.
- Prior involvement in regulatory inspections or audits (e.g., FDA, Notified Bodies).