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

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!

Your tasks:

• 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

• 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

Your profile:

• University degree in a relevant field, such as natural sciences, engineering, quality and regulatory, business economics, or similar
• PMP-PMI certification is required; additional certification in Change Management is a plus
• 8-12 years managing quality and regulatory projects, including 3+ years leading cross-functional teams, 5 years of professional experience in a regulated environment (MedTech or Pharma)
• Skilled in stakeholder management, with the ability to communicate effectively across all levels of an organization
• Proven ability to manage multiple projects in a fast-paced environment with evolving priorities, strong time management, and delivery within established timeframes
• Able to analyze complex data, interpret insights, and make critical decisions on challenging issues promptly and effectively
• A proactive, positive leader who motivates teams, mentors others, and promotes a collaborative environment for successful project outcomes
• Experienced in implementing change management strategies to navigate organizational transitions effectively
• Proficient in PPPM software tools and advanced Microsoft Office applications
• Fluent in English, both written and spoken
• Willingness to travel within the EMEA region as needed