Global Complaint Manager (m/f/d)
Posted 14 days 11 hours ago by B. Braun Melsungen AG
For more than 175 years, B. Braun has been putting the joy back into people's lives and helping them to achieve new goals. People like David Drahonínský, for whom our catheters have eased the challenges of life in a wheelchair. Each day, over 60,000 committed employees around the world share their skills and knowledge at B. Braun. Join us and develop your talents with us asGlobal Complaint Manager (m/f/d)
Reference Code AM6
Within B. Braun Avitum AG, Post Market Surveillance (PMS) department, we are looking for a Global Complaint Manager (m/f/d) for our Group headquarters in Melsungen, at the earliest possible date.
The Post Market Surveillance (PMS) department is responsible for the monitoring of the product safety of medical devices and pharmaceuticals post market, in compliance with national and international reporting obligations according to the respective legal and regulatory requirements.
We are the contact partner for Authorities, B. Braun country organizations and distributors of B. Braun Avitum AG products in more than 90 countries, based on a close cooperation with our production sites and many other departments of B. Braun Avitum AG.
- Coordination and documentation of international complaints in accordance with legal and regulatory requirements
- Administrative support and documentation of FSCAs / Recalls
- Transfer of current regulatory requirements from new markets into the organization
- Transfer of new regulatory requirements into the organization
- Ensuring compliance, training, implementation and optimization of the complaint management process
- Development, maintenance and optimization of the computer application SAP R3 "Customer Complaint Coordination" for the application within the division B. Braun Avitum
- Development and support of the complaint-responsible sites
- Initiation of the processing activities and monitoring of the complaints according to defined SAP R3 C3 workflows
- Registration of feedback of organizational units without SAP R3 connection
- Documentation and archiving of complaints in accordance with defined processes
- Trend analysis of the complaint data for all product groups at specified time intervals according to defined processes
- Target group-oriented reporting as part of the management review process
- Co-operation in CAPA working groups of the individual product groups
- Presentation of processes in internal and external quality management audits
- Graduation in medical technology, sciences, business administration or engineering
- Competent knowledge of the regulatory and legal requirements in PMS and related subject areas
- Product know how in dialysis desirable
- Audit experience desirable
- Very good command of spoken and written English
- Profound technology understanding
- Strengths of implementation and negotiating skills with focus on the essential.
- Structured and conceptional working method, analytical skills as well as entrepreneurial mindset
- High communication and social skills, also 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.
Your next step
Contact: B. Braun Avitum AG | Anna Mey | 05661/ |