November 8, 2024

Fresenius Medical Care

Bad Homburg vor der Höhe

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:
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

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 (Med Tech 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