Bayt.com
https://bayt.page.link/cWob23BNq7vtwspX7
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Job Description

Areas of responsibility include: 
  • Leading the Complaint assessment board meeting to review, assess and report of incoming complaints.
  • Leading/participating in the reporting decision meeting in case of potential adverse events
  • Initiating and timely monitoring of Complaint investigations, information- or complaint part requests
  • Review and evaluation of investigation results.
  • Communication of complaint investigation results and closure of Complaints
  • Coordination of complaint management and reporting activities according to legal, normative and internal requirements
  • Provide information of reportable Adverse Events to Regional Reporting Unit
  • Maintenance of Complaint File, Adverse Event and Field (Safety) Corrective Action records
  • Maintenance of internal process documents
  • Support or participation in internal and external audits
  • Entry point of authority communication
  • Reporting of authority communication to management and involved parties

Qualification and experience:
  • Technical diploma
  • Knowledge of the relevant complaint and vigilance related processes in foreign markets like Europe, USA, China etc.
  • At least 2 years of professional experience in the field for medical devices.
  • Intercultural experiences especially working in a global multi-site team across countries
  • Structured, reliable and goal-oriented way of working.

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