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Manager - Product Surveillance

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Job Type
Direct Hire
Jan 31, 2017
Job ID

Manager - Product Surveillance
Main Objective: Ensure compliance in the areas of complaints, consisting of but not limited to; FDA Med Watch filing, CMDCAS Adverse Event filing, MDD Vigilance Reporting.
Essential Duties and Responsibilities:
  • Supervises and directs the efforts of the Complaints Department
  • Reviews and approves complaints and complaint closure letters
  • Responsible for the coordination of worldwide complaint data into appropriate management reports, analyzing trend data associated with complaints, drawing appropriate conclusions to trend data and presenting such data in a meaningful, usable format to management
  • Responsible for interfacing with customers, distributors and doctors regarding complaint issues
  • Participate in Management Review Meetings to disseminate complaint data
  • Responsible for assuring the integrity and completeness of Complaint Files
  • Responsible for staffing, positioning, hiring and disciplinary action (as necessary) the Complaints Department
  • Responsible for maintaining procedures and practices related to complaint handling to assure compliance with ISO and FDA regulations
  • Responsible for assuring timely review and closure of complaints
  • Responsible for assuring complaints personnel are properly trained in all procedures and SOPs
  • Responsible for maintaining efficient work flow, work assignments and throughput
  • Responsible for participating in FDA and ISO audits, as well as other 3rd party inquiries as required. 
    Education and Experience:
  • Bachelor’s degree in engineering, business, regulatory compliance or related areas required.
  • 3 years senior level experience in handling complaints in an FDA /ISO regulated environment.
  • 2 years of management experience. 
    Knowledge and Skill Requirements/Specialized Courses and/or Training:
    Knowledge of FDA and ISO regulations regarding complaints and reportable events, excellent proven interpersonal skills in dealing with all levels of professionals