Senior Vigilance & PMS Specialist

Senior Vigilance & PMS Specialist

Overview
Our client is one of the leading companies in the fields of orthopedics, arthroscopy, and sports medicine. They are a global manufacturing company with a family business spirit and an ambition to produce uncompromising quality for the healthcare professionals who use their products and for the millions of patients whose lives they ultimately impact.


Tasks

  • Coordination, creation and timely submission of vigilance reports in the EMEA region in collaboration with the different departments
  • Evaluation of potential reportable incidents
  • Involvement in the continuous optimization of complaints handling procedures and processes
  • Keep track of and handle national and international product complaints in accordance with current regulatory requirements, which includes coordinating and monitoring further development
  • Undertake corrective actions/recalls ("Field Safety Corrective Actions")
  • Management of internal projects
  • Creation of complaints related statistics
  • Participation in internal and external audits

Your profile
  • Successful completion of a scientific, medical or technical degree or equivalent qualification
  • Relevant professional expertise working with medical devices or other products that are subject to similar regulations
  • Thorough knowledge of the international regulatory requirements on customer complaints and reportable events (2017/745 MDR)
  • Proficient in the standard MS Office applications
  • Attentive, trustworthy, and well-organized working style
  • Fluency in German and English (both written and spoken)


Please apply with your CV or contact May-Lynn Capocciama-Knecht for further details on this opportunity and additional vacancies in Regulatory Affairs and Quality Management.
may-lynn.ck@adaptivelifescience.com
+49 30 1663 7750


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