Jennifer Benavidez
Regulatory Affairs Associate Specialist @Edwards Lifesciences
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WORK HISTORY
Regulatory Affairs Associate Specialist @Edwards Lifesciences
Gathers documents to assist with submission preparation and dossier compilation/updates for Class implantable devices to US/EU/Canada, including deliverable tracking, formatting, and final packaging - Led the documentation management for multiple products MDR transition, PMA, and IDE (Pivotal/EFS)- Maintains data metrics for department to provide quarterly updates to upper management - Supports RA Systems process improvement implementation projects for change assessments and submission creation/storage - Process invoices and tracks payments to CRO (Clinical Research Organization) through internal systems - Standardized and maintains archive of communications and correspondences from regulatory agencies, included as part of data analytics
EDUCATION
University of California, Riverside
Bachelor's degree, Psychology
Palomar College
Marketing
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