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Join to apply for the Risk Analyst - Urgent Need role at MillenniumSoft Inc Join to apply for the Risk Analyst - Urgent Need role at MillenniumSoft Inc Level of Experience : Mid-Level Employment Type : Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT) Summary The Risk Analyst is responsible for identifying and assessing potential risks associated with the use of a medical device, and for developing strategies to manage those risks. They bring strong product knowledge and collaborate with cross functional resources to define sequences of events which may lead to harm, thus supporting the overall risk assessment. They will support the creation and maintenance of compliance artifacts to be stored in the DHF (Design History File). Position : Risk Analyst Location : San Diego, CA Duration : 12 Months Total Hours/week : 40.00 1st Shift Client : Medical Devices Company Job Category : Engineering/Technical Level of Experience : Mid-Level Employment Type : Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT) Summary Job Description: The Risk Analyst is responsible for identifying and assessing potential risks associated with the use of a medical device, and for developing strategies to manage those risks. They bring strong product knowledge and collaborate with cross functional resources to define sequences of events which may lead to harm, thus supporting the overall risk assessment. They will support the creation and maintenance of compliance artifacts to be stored in the DHF (Design History File). Responsibilities Review existing product hazards and define the sequence of events for each Identify and document new hazards and risks control measures for medical device products Maintain accurate risk management artifacts Apply knowledge and understanding of ISO 14971 Participate in product development and design reviews to identify potential risks and provide input for risk mitigation. Skills And Competencies Knowledge of risk assessment methodologies and tools. Strong analytical skills and attention to detail. Excellent communication skills Qualifications And Experience Bachelor’s degree in computer science, healthcare, or related field 3-5 years of experience in Risk Management, preferably in a regulated industry Seniority level Seniority level Mid-Senior level Employment type Employment type Full-time Job function Job function Finance and Sales Industries Staffing and Recruiting Referrals increase your chances of interviewing at MillenniumSoft Inc by 2x Get notified about new Risk Analyst jobs in San Diego, CA . Risk Manager, Extended Producer Responsibility, RISC (Program) - EPR Business Analyst – Financial Services PMO Governance, Risk, and Compliance Manager San Diego, CA $95,000.00-$111,000.00 12 hours ago Sr. Risk Manager, Sales Abuse, Sales Abuse Prevention Del Mar, CA $98,716.00-$162,999.00 1 day ago National City, CA $68,640.00-$99,424.00 5 days ago San Diego, CA $165,500.00-$231,500.00 3 hours ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr