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Senior Complaint Manager – mylife Diabetes Care AG | JobRevolt

Über den Job

mylife Diabetes Care ist ein global tätiges Medizintechnologieunternehmen mit Fokus auf integrierte Lösungen für Menschen mit Diabetes. Zur Verstärkung des Teams wird eine erfahrene Fachperson gesucht, die Verantwortung für komplexe und kritische Reklamationsfälle übernimmt und eng mit Vigilance & Post Market Surveillance, Regulatory Affairs, Medical Affairs und Risk Management zusammenarbeitet, um Patientensicherheit und regulatorische Compliance sicherzustellen.

Aufgaben

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

Profil

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 (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

Rahmenbedingungen

Pensum: 100%
Ref. No. 273
Standort: Burgdorf | Hybrid
Kontakt: Alban Haliti, Talent Acquisition Partner
mylife Diabetes Care AG, Lyssachstrasse 40, CH-3400 Burgdorf, Switzerland

Benefits

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: 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

Senior Complaint Manager

Über den Job

Über den Job

Aufgaben

Profil

Rahmenbedingungen

Benefits

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