Required skills
- Medical Technology
- Complaint Handling
- Investigation
- PMS
- Vigilance
- Regulatory Affairs
- MPG
- MDR
- FDA
- ISO9001
- ISO13485
- Trackwise
Languages: German
Job description
Manage and conduct root cause analyses and evaluations for complaints in the Intensive Care sector. Process and respond to complaints according to applicable processes, documenting results and coordinating with product teams.
Responsibilities
- Management and execution of root cause analyses and evaluations for complaints from the Intensive Care sector
- Processing and answering complaints according to applicable processes, documenting the results in Trackwise and coordinating with the responsible product teams
- Analysis of standard and non-standard complaints as well as participation in an encyclopedia for standard answers
- Coordination and definition of standards between the Engineering Team and Post Market Surveillance
Requirements
- Completed degree or qualified and specialized professional experience for the tasks described in medical technology
- Initial professional experience in complaint handling and investigation is desirable
- Experience in the area of PMS and Vigilance
- Very good written and spoken German and English skills
- Regulatory knowledge, especially MPG, MDR, FDA, ISO9001 and ISO13485
Project details
- Start: 2027-01
- Duration: 24 Monate
- Remote: hybrid
- Location: Lübeck, Deutschland, DE
- Languages: German
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