As a Risk Manager at our Rostock or Valencia site, you will be a key member of our Germany-based Quality Management & Regulatory Affairs team. You will ensure compliance with international quality standards and regulatory requirements and continuously develop and improve all risk-related processes.

Key Responsibilities

• Manage the risk management system for our in vitro diagnostic medical devices, laboratory processes, and business continuity through profound analysis of process parameters and in-process controls
• Identify risks and risk mitigation measures in a cross-functional team
• Create and maintain risk management files for our globally offered in vitro diagnostic medical devices in accordance with ISO 14971
• Coordinate the system for nonconformities, CAPAs, and complaint handling with regard to risk management
• Provide input to further develop the quality management system in accordance with ISO 13485, ISO 15189, FDA QMSR, and IVDR (EU) 2017/746