Risk Manager

As a Product Risk Management Specialist, your role involves planning and executing risk management activities for medical devices and health software products in an agile development and operations environment. You will collaborate with project management and cross-functional teams to identify, evaluate, and mitigate potential safety risks associated with the use of the products. Your responsibilities include tracking the implementation of risk control measures, analyzing industry and regulatory information, participating in product design reviews with a focus on risk management, and maintaining risk management files. Additionally, you will participate in audits, support the growth of the risk management community, and enhance risk management processes. Key Responsibilities: - Plan and execute product risk management activities in an agile environment - Identify and evaluate safety risks, and develop mitigation measures - Track implementation of risk control measures - Analyze industry and regulatory information for potential risks - Participate in product design reviews with a focus on risk management - Maintain product risk management files - Participate in audits and assessments - Support the growth of the risk management community - Enhance risk management processes Qualifications and Experience: - Masters degree in engineering or Medical-Technical expertise with a sound software background - 15+ years of experience in the medical device industry, preferably in SaMD - Experience in using medical devices in a clinical setting, risk management, or project management in software development - Methodological and practical experience in risk management for medical devices and health software - Familiarity with relevant standards and regulations such as MDR, ISO 14971, IEC 62304, IEC 82304, ISO 13485, ISP 62366 - Experience working with international teams and proficiency in written and spoken English - Strong communication, assertiveness, self-motivation, analytical, and critical thinking skills.,