Senior Expert (m/f/d) Quality and Regulatory Affairs EMEA

at  Fresenius Medical Care

Fresenius Medical Care is the world’s leading provider of products and services by offering innovative products and treatment concepts of the highest quality. We continuously want to improve the quality of life for our dialysis patients, worldwide and every day.
Join our team and play a pivotal role in shaping the future of dialysis care, driving impactful innovations and strategies that enhance patient outcomes on a global scale!

Q&R Project Management and Functional Leadership across the EMEA Hub

• Provide project management expertise to identify, define and outline the scope of Q&R projects goals, deliverables across the EMEA region in close collaboration with supervisor
• Built and lead cross-functional Q&R project teams within the EMEA region
• Lead, implement and follow-up Q&R projects & IT dedicated tools
• Manage Q&R project initiatives through effective project management ensuring projects are performed in accordance with established processes and procedures, and in compliance with company and regulatory guidelines and requirements.
• Develop and provide reports and project status defining project progress, issues and solutions
• Acts as a liaison between various internal groups/departments and/or external resources, as required, for managing the Q&R project from concept to implementation, and stabilization.
• Monitor and manage issues and risk management efforts assessing project plans
• Highlight potential areas of concern, recommend options to adjust project priorities to manage changes and resources and assess impact of changes to project scope
• Develop and implement methods and tools by which to organize, standardize, and manage Q&R project activities
• Partner and collaborate with functional and operational leaders across the organization, to ensure smooth organizational transitions as required
• Lead efforts to develop, maintain, continuously improve, and communicate best practices, processes, procedures, standards, methodologies, techniques, and technology

Quality & Regulatory across the EMEA Hub

• Support in negotiations with key health authority agencies during development, registration, and product lifecycle activities to resolve regulatory issues and/or negotiate approvals; establish and maintain proactive and professional communication & relationship with agencies
• Give guidance on how to prepare, execute and maintain regulatory submissions
• Support in monitoring, evaluating and informing key internal stakeholders about applicable national regulatory requirements
• Coordinate internal implementation and actively contribute to the development of new regulatory requirements