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Job Responsibilities:

Evaluate and escalate risk.  Aggregate and analyze data from multiple sources (e.g., signal detection, medical review, etc.) and identify common trends  Use sound judgment to identify novel events and new risks, then make recommendations to escalate or provide rationale regarding why escalation is not necessary.  Actively engage with product engineers and medical officers across the organization to ensure evaluation of product risk considers multiple inputs.  Ensure compliance with ISO 14971 (Risk Management) standards.  Create risk management plans, assess product risks, and create risk management reports. 

Detailed Job Description:

Bachelor of Science Degree  3-5 years of dedicated experience with product risk per ISO 14971  Ability to interpret basic statistical data and graphs  Proficiency in Microsoft Office Suite  A critical eye for detail  Ability to work cross-functionally

Experience required: 5 Years