Title:  Complaint Manager

Your main tasks

• Responsible for processing incoming complaints in accordance with applicable process specifications
• Independent processing and assessment of complex or critical complaint cases with potentially high risk to patient safety or regulatory compliance
• Coordination and moderation of interdisciplinary teams in complex root cause analyses (RCA)
• Conducting and supporting trend analyses and deriving preventive measures to avoid errors
• Working closely with Vigilance & Post Market Surveillance, Regulatory Affairs, Medical Affairs, Risk Management and Product Care, as well as external partners
• Supporting the further development and optimisation of complaint processes and procedures in accordance with current regulatory requirements and best practices
• Assumption of the role of subject matter expert (SME) for complaint management in the context of audits and regulatory inspections
• Support in the development and implementation of training concepts and internal training programmes in the area of complaint management

Your profile

• Several years of professional experience (> 5 years) in complaint management or post-market surveillance in a regulated environment (medical technology – preferably with Class 1, 2a and 2b products or pharmaceuticals)
• In-depth knowledge of regulatory requirements, in particular: EU MDR 2017/745 and ISO 13485, 21 CFR 820 is an advantage
• Experience in data analysis and use of complaint and quality databases (e.g. TrackWise)
• Analytical thinking and strong problem-solving skills
• Very good organisational and communication skills, combined with an independent and self-reliant approach to work
• Committed team player with very good written and spoken German and English skills