Senior Complaint Manager

Description du poste

mylife Diabetes Care is a global medical technology company focused on integrated solutions for people with diabetes. As a growing company, we continue to develop our organization with a clear strategy, ambitious growth goals, and plenty of room for personal responsibility. To strengthen our team, we are looking for an experienced professional who takes ownership of complex and critical complaint cases. Guided by our mission of engineering miracles for people living with diabetes, you will work closely with Vigilance & Post Market Surveillance, Regulatory Affairs, Medical Affairs, and Risk Management to ensure that every complaint is handled in a way that protects patient safety and regulatory compliance. Senior Complaint Manager | 100% Ref. No. 273 Location: Burgdorf, Burgdorf | Hybrid Help us bring to market state-of-the-art medical technology solutions by optimizing processes and ensuring quality through your structured approach. 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 Support and deputy for the Complaint Management Manager 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 Experience the benefits of working with us Pension fund mylife Diabetes Care 55% of the pension contributions Mobility support Charging stations, Swiss Half Fare Card, parking, close to public transport Free sport facilities affordable or free gyms Family friendly Financial contributions to childcare Working hours working time arrangements: Shiftwork, annual working hours, part-time FlexWork Work where and when you want (in Switzerland) Up-to-date work environment Modern offices and production rooms; staff restaurant and break areas Together, we create solutions that improve lives. At mylife Diabetes Care, we develop integrated solutions that people with diabetes can truly rely on. We are a fast-growing, family-owned company headquarterd in Burgdorf (Switzerland) – built on 40 years of innovation and active internationally. We bring together expertise, dedication and a clear mission: empowering people to gain more freedom through better control. Everything we do is developed with purpose and designed with care. Our core competence lies in automated insulin delivery (AID). With mylife Loop, we provide a system that adapts to the individual needs and everyday lives of people with diabetes. Contact Alban Haliti Talent Acquisition Partner Write an email Lyssachstrasse 40 CH-3400 Burgdorf Switzerland T +41 (0)58 234 70 00 Write an email