Location: Freemont CA
· Reviews and determines reportability of complaints to FDA and international regulatory authorities.
· Writes, reviews, and files Medical Device Reports (MDRs) and international Vigilance Reports.
· Works closely with Sales Representatives and health care professionals to obtain additional information.
· Monitors quality, completeness and timeliness of complaint investigations.
· Writes customer response letters.
· Contributes to achieving team performance metrics and goals.
· Other duties as assigned.
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