Initiates and manages the complaint file, maintains accurate entry of complaints in the database, communicates to field representatives regarding the information needed specific to product complaints (e.g. physicians, hospital personnel, sales representatives, international offices), independently assesses the complaint to determine if a medical device report needs to be filed with various global regulatory agencies (e.g. FDA, ECA) and submits reports within required timeframe, diligent of any unusual trends in product complaints and communicates them with mgmt.,
complies with US FDA regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments
Maintains positive and cooperative communications and collaboration with all levels of employees, customers, and contractors.
Performs other related duties and responsibilities as assigned
Seniority level
Associate
Employment type
Contract
Job function
Manufacturing
Industries
Medical Equipment Manufacturing, Biotechnology Research, and Pharmaceutical Manufacturing
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