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Post Market Quality Specialist

VirtualVocations
Garland, Texas, United States
Full-time

A company is looking for a Post Market Quality Clinical Specialist to manage adverse event reporting and compliance in the medical industry.

Key ResponsibilitiesAssess and submit reports for potential adverse events and serious injuries in compliance with regulationsSupport complaint handling and follow up with internal departments and end users for additional informationParticipate in audits and innovate processes to enhance efficiency and compliance in post-market surveillanceRequired Qualifications and Education3+ years of experience in reporting / filing MDRs to the FDA in the medical industryBachelor's degree in a related field such as nursing, biomedical engineering, or similarPrevious experience with Medical Device Reporting and a clinical backgroundKnowledge of FDA regulations, ISO 13485, ISO 14971, and EU MDRAdvanced level of Spanish is preferred

10 days ago
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