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Take part in post-market safety surveillance activities for assigned medical devices and contribute to area projects and objectives. Identify issues and escalate them to the manager as necessary. Conduct medical safety assessments (MSA) for medical device complaints involving reported adverse events and, occasionally, technical events. This involves evaluating the seriousness of adverse events, determining device relatedness, and assessing whether a recurring malfunction could cause or contribute to serious injury or death. Maintain oversight of all incoming MSAs for timely completion to assist in on-time reporting.
Job Responsibility:
Take part in post-market safety surveillance activities for assigned medical devices and contribute to area projects and objectives
Identify issues and escalate them to the manager as necessary
Conduct medical safety assessments (MSA) for medical device complaints involving reported adverse events and, occasionally, technical events
This involves evaluating the seriousness of adverse events, determining device relatedness, and assessing whether a recurring malfunction could cause or contribute to serious injury or death
Maintain oversight of all incoming MSAs for timely completion to assist in on-time reporting
Requirements:
BSN Degree or higher with active RN license
Minimally 5-7 years of hands-on clinical experience
Able to apply clinical knowledge to adverse event data collection and assessment
Competent in ability to present device safety event data, orally and in writing
Adheres to policies and regulations
Must be Computer proficient (Windows, Word, Excel)
What we offer:
medical insurance
dental insurance
vision insurance
401(k) retirement plan
life insurance
long-term disability insurance
short-term disability insurance
paid parking/public transportation
(paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)