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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