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Risk Analyst

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) Position Risk Analyst Location San Diego, CA Duration 12 Months Total Hours/week 40.00 Shift 1st Shift Client Medical Devices Company Job Category Professional 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 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 #J-18808-Ljbffr MillenniumSoft Inc

Vacancy posted 1 day ago
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