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
#LI-MC2