Risk Management Expert
Core
Ensuring the safety of medical devices by applying the risk management process throughout the product life cycle.
Role type
Risk Management Expert (Medical Devices)
Builds
Risk analyses and Risk Management Files for medical devices, medicinal products, and digital/non-medical devices.
Domain
Healthcare / Medical Devices / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Risk evaluation, knowledge of medical device regulations (MDR, MDSAP, ISO 13485, ISO 14971), scientific writing, statistical methods, knowledge of dialysis and related therapies
Preferred skills
TrackWise/QTRAK, PDM tools (Windchill), FMEA tools
Technologies
MS Office, Outlook, SharePoint, Teams
Responsibilities
Lead planning and execution of the risk management process, develop and maintain risk analyses and Risk Management Files, define risk-reduction measures, participate in product development and design reviews, support Design/Process/Software FMEAs and anomaly management, conduct risk assessments, provide support during production transfer, contribute to quality-system risk assessments, support creation of post-market safety documentation
Seniority
Mid-level, hands-on IC