Postmarket Surveillance Analyst II
Postmarket Surveillance Analyst II
Intellectt Inc
Plano, TX
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Role: Postmarket Surveillance Analyst II
Location: Plano, TX - 75024
Duration: 6 Months
Shift Timings: 8 AM to 5 PM
Job Description
Initiates and manages the complaint file, maintains accurate entry of complaints in the database, communicates to field representatives regarding 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, contractors.
Location: Plano, TX - 75024
Duration: 6 Months
Shift Timings: 8 AM to 5 PM
Job Description
Initiates and manages the complaint file, maintains accurate entry of complaints in the database, communicates to field representatives regarding 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, contractors.
-
Seniority level
Associate -
Employment type
Full-time -
Job function
Finance and Sales -
Industries
Staffing and Recruiting
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