Intellectt Inc

Postmarket Surveillance Analyst

Intellectt Inc Plano, TX
Intellectt Inc

Postmarket Surveillance Analyst

Intellectt Inc Plano, TX
5 months ago
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Role: Postmarket Surveillance Analyst II

Location: Plano, TX - 75024

Duration: 12+ 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.
  • Performs other related duties and responsibilities as assigned

  • Seniority level

    Associate

  • Employment type

    Full-time

  • Job function

    Finance and Sales

  • Industries

    Staffing and Recruiting

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