Risk management expert

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7b7t2t

Experteer Overview As a Risk Management Expert, you ensure the safety of medical devices by applying risk management processes throughout the product lifecycle. You will identify and address risks in line with the Risk Management Plan and oversee planning and execution of all risk activities. You will prepare and maintain risk analyses and risk management files for devices and therapies, in compliance with applicable standards. You join cross-functional teams to define risk-reduction measures and support post‐market safety documentation, enabling safer patient care and regulatory compliance. Key Responsibilities Lead planning and execution of the risk management process in line with standards and regulations. Develop, update, and maintain risk analyses and the Risk Management File across the product lifecycle. Define effective risk‐reduction measures with cross‐functional partners and the Value Stream. Ensure risk management activities align with the approved Risk Management Plan. Participate in product development and design reviews to verify risk identification and mitigation.



Support and review FMEAs and anomaly management activities. Conduct and integrate risk assessments into the overall risk analysis. Provide risk management support during production transfer and ongoing manufacturing activities. Contribute to quality‐system risk assessments (complaints, non‐conformances, CAPAs) and Health Hazard Assessments. Support the creation of post‐market safety documentation (e.g., PSUR, CER) and act as SME for risk management in cross‐functional teams. Qualifications Scientific degree and minimum 2 years in Regulatory Affairs or Quality in pharma/medical device. Proven experience in risk evaluations and knowledge of MDR, MDSAP, ISO 13485, ISO 14971. Experience in scientific writing and familiarity with statistical methods. Knowledge of medical devices, including dialysis and related therapies. Strong analytical, organizational, and decision‐making skills with autonomou

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7b7t2t