Post Market Quality Specialist
Company: VirtualVocations
Location: Asheville
Posted on: October 27, 2024
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Job Description:
A company is looking for a Post Market Quality Clinical
Specialist to manage adverse event reporting and compliance in the
medical industry.
Key Responsibilities
Assess and submit reports for potential adverse events and serious
injuries in compliance with regulations
Support complaint handling and follow up with internal departments
and end users for additional information
Participate in audits and innovate processes to enhance efficiency
and compliance in post-market surveillance
Required Qualifications and Education
3+ years of experience in reporting/filing MDRs to the FDA in the
medical industry
Bachelor's degree in a related field such as nursing, biomedical
engineering, or similar
Previous experience with Medical Device Reporting and a clinical
background
Knowledge of FDA regulations, ISO 13485, ISO 14971, and EU MDR
Advanced level of Spanish is preferred
Keywords: VirtualVocations, Rock Hill , Post Market Quality Specialist, Other , Asheville, South Carolina
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