Complaint Manager

Your main tasksResponsible for processing incoming complaints in accordance with applicable process specificationsIndependent processing and assessment of complex or critical complaint cases with potentially high risk to patient safety or regulatory complianceCoordination and moderation of interdisciplinary teams in complex root cause analyses (RCA)Conducting and supporting trend analyses and deriving preventive measures to avoid errorsWorking closely with Vigilance & Post Market Surveillance, Regulatory Affairs, Medical Affairs, Risk Management and Product Care, as well as external partnersSupporting the further development and optimisation of complaint processes and procedures in accordance with current regulatory requirements and best practicesAssumption of the role of subject matter expert (SME) for complaint management in the context of audits and regulatory inspectionsSupport in the development and implementation of training concepts and internal training programmes in the area of complaint management Your profileSeveral 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 advantageExperience in data analysis and use of complaint and quality databases (e.g. TrackWise)Analytical thinking and strong problem-solving skillsVery good organisational and communication skills, combined with an independent and self-reliant approach to workCommitted team player with very good written and spoken German and English skills