This is a rapidly growing MedTech company transforming radiation therapy for cancer patients with 3D surface tracking the radiotherapy workflow. With around 300 employees globally and offices in the UK, Poland & the USA, it combines the security of a large global enterprise with the agility of a startup.
The company has strong values, a clear mission and a bright future. It’s an exciting and rewarding place to work.
About the role
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. As a Senior Risk Management Engineer, you will play a critical role in ensuring the safety and compliance of our medical devices throughout their lifecycle.
Key Responsibilities
* Lead the creation, maintenance, and continuous improvement of comprehensive Risk Management Files in accordance with ISO 14971, including Risk Traceability Matrices
* Manage 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 with systems, software and hardware teams
* Lead anomaly review boards, assign severity scores, and ensure timely risk mitigation strategies
* 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
* Demonstrate 5+ years of experience in risk management for medical devices, ideally in a regulated Class II or III environment
* Deep knowledge of ISO 14971 and ISO/TR 24971, with a track record using 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 re-evaluation based on real-world data
* Proficiency with ALM tools such as Polarion, MatrixALM, DOORS, or Enterprise Architect
* Strong analytical and organizational skills to manage multiple priorities and deadlines
* Excellent communication skills 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
* Familiarity with IEC 62366-1 (Usability Engineering) and IEC 60601-1-2 (EMC)
* Experience working 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
* Manufacturing and Engineering
* Industries: Medical Equipment Manufacturing
EEO and other legal requirements should be reviewed separately according to locale. Referrals may increase interview likelihood.
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