Global Complaint Manager (f/m/d)

Within B. Braun Avitum AG, Post Market Surveillance (PMS) department, we are looking for a Global Complaint Manager (f/m/d) for our corporate headquarters in Melsungen as soon as possible.

The Post Market Surveillance (PMS) department is responsible for monitoring the product safety of medical devices and medicines after market launch in compliance with national and international reporting obligations in accordance with the respective legal and regulatory requirements. As a Global Complaint Manager, you will be the central point of contact for authorities, B. Braun national organizations and distributors of B. Braun Avitum AG products in over 90 countries and work closely with our production sites and many other departments of B. Braun Avitum AG

Duties and responsibilities

• Coordination and documentation of international complaints in compliance with legal and regulatory requirements
• Ensuring the implementation, training, compliance and optimization of the defined complaint management process
• Development, maintenance and optimization of the IT application SAP/R3 „C3 Customer Complaint Coordination“ in cooperation with specialist departments for the B. Braun Avitum division
• Support and development of the locations responsible for complaints
• Request additional information about the complaint if the existing data does not allow processing
• Initiation of processing activities according to the defined SAP/R3 C3 workflows
• Monitoring Complaint Processing Activities in SAP/R3 C3
• Sending of processing reminders to the processors of complaints in the event of non-compliance with the processing deadlines
• Entry of Processing Confirmations from Organizational Units without SAP/R3 Connection
• Contact person for inquiries about the processing status of complaints
• Documentation and archiving of complaints according to the defined processes
• Conducting trend analysis of complaint data for all product groups at specified time intervals according to the defined processes
• Target group-oriented reporting as part of management review processes
• Participation in CAPA working groups of the individual product groups
• Presentation of processes in internal and external quality management audits
• Collaboration in the implementation of FSCA Field Safety Corrective Action/Recall
• Collaboration in the further development of the PMS system and the corresponding database system
• Collaboration in the creation of PMS plans and reports
• Transfer of current regulatory requirements from new markets into existing processes
• Integration of new regulatory requirements into existing processes

Professional competencies

• Successfully completed bachelor’s degree in the fields of medical technology, natural technology, business and engineering
• Several years of experience in the field of complaint processing or several years of experience in the field of dialysis products
• Relevant knowledge of the regulatory and legal requirements in the field of PMS and related areas
• Product knowledge in the therapeutic field of dialysis desirable
• Audit experience desirable
• Very good written and spoken English skills
• High level of technology understanding

Personal competencies

• You have implementation skills and negotiation skills with an eye for the essentials
• Structured, conceptual way of working as well as very good analytical skills are among your strengths
• You are characterized by precise, structured communication as well as a high level of social competence and the ability to work in a team, even in an intercultural environment

What we offer

Become part of a corporate culture that actively promotes constructive exchanges between colleagues, customers and partners. Work with us to improve people’s lives in the long term. We can offer you interesting, varied tasks and excellent opportunities for advancement, as well as an attractive salary with extensive benefits, all within a dynamic family-owned company.

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