Detalles de la oferta

.**Descripción y detalle de las actividades**- Reviews all product complaints entered into the complaint handling data base by Customer Service/Sales, to ensure accuracy of the data entered to include but not limited to the product indicated aligns with the complaint statement made by the customer. Evaluates, assigns investigation(s), and tracks timely completion and closure of complaints. Ensures the integrity and completeness of Complaint Files prior to closure. Responsible for reviewing all product complaints to differentiate between serious and non-serious complaints and determine reportability to worldwide regulatory agencies within the required timeframes. Reviews and approves complaints and complaint closure information for completeness using Good Documentation Practices while interpreting and analyzing statistical data to identify trends. Oversees product complaint investigations to resolution while ensuring documentation of clear, complete and timely investigations that are supported by data in accordance with company procedures and regulatory compliance. Responsible for assuring timely review and closure of complaints while maintaining efficient workflow, work assignments and throughput. Ensures accurate documentation of evaluation and investigation results with the assigned complaint records. Has primary responsibility in overseeing the complaint handling data base in accordance with documented procedures to ensure data integrity, regulatory compliance, and customer satisfaction. Reviews global medical device complaints for the identification of reportable events in the local countries and for any reciprocal reporting requirements within the required timeframes including but not limited to Medical Device Reports (MDR) and Medical Device Incident Reports (MDIR). Responsible for the submission of US MedWatch reports and ensuring US reportable events are reviewed prior to submission and submitted within the required timeframes. Prepares formal reports for adverse event complaint responses to regulatory authorities


Salario Nominal: A convenir

Fuente: Jobtome_Ppc

Requisitos

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