Complaint Analyst II - Irvine, United States - Tekwissen

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    Description

    The Complaints Specialist will be responsible for maintaining the quality processes associated with regulatory reporting and its procedures/controls to ensure that all MDR reportable complaints are processed and submitted in accordance with established company procedures and worldwide regulations and standards.

    The candidate will review reportable and potentially reportable complaints from incoming calls faxes and emails from all areas of the world.

    The candidate will also ensure adequate information is received to warrant timely reporting investigation and closure of reportable complaints including sound regulatory reporting decisions/justifications for worldwide reporting.

    The individual applies standard practices and procedures adjusts and correlates data recognizes discrepancies in results and follows operations through a series of related detailed steps and processes.

    Essential Duties and Responsibilities Responsible for the customer complaints regulatory reporting process (timely submissions timely closure health authority requests etc.).

    Responsible for ensuring all required information for a complaint file is obtained and properly documented to make sound regulatory reporting decisions.

    Evaluates all information from a clinical and technical perspective to ensure appropriate Analysis Investigation Root Cause and Quality Engineering review is