- Qualification, monitoring, and management of critical business partners/service providers (e.g., TPIs) for FME D GmbH to ensure regulatory compliance of distribution channels to the end consumer based on valid processes and regulatory requirements within the respective area of responsibility - QAA control (timely creation, completion, and maintenance based on centrally provided templates) - Support with Initiation of mapping measures for the qualification and support of distributors, pharmaceutical wholesalers, and critical service providers - Collaboration with the drafting, updating and maintaining quality assurance agreements with distributors, wholesalers and critical service providers in close cooperation with Q & R Hub - Provide oversight over QAA status with TPIs/FME subsidiaries and respective reporting to relevant stakeholders - Interface management for operational questions to the QAA with, for example, DGRA, Labelling Office, GTO, TPI Governance,



Medical Device Vigilance and Trading Goods Department regarding their impact on TPI QAAs - Preparation and support in internal and external surveillance audits - Support with preparation of other service level or service agreements - Implementation of quality assurance mapping measures - Collaboration in international and cross-departmental project work - After obtaining the appropriate auditor qualification, conducting audits of critical service providers (e.g., distributors, FME marketing & sales organizations within the framework of the quality management system or audits with a changed or extended scope, such as ISO 13485, GDP, etc.) - The position holder will take on project tasks in the area of Regulatory Affairs & QMS International that are initiated to ensure compliance with external requirements as well as to support the identification, definition, implementation, monitoring, reporting, and follow-up of corporate processes and directives

📌 Senior Specialist- Distributor Management (Bengaluru)
🏢 Fresenius Medical Care
📍 Bengaluru