Quality, LMR & EHS Cluster Expert

At Fresenius Medical Care, we are committed to improving the lives of people with chronic kidney disease through innovative, high‑quality products, therapies and patient care. Guided by our vision “Creating a future worth living. For patients. Worldwide. Every day.”, our global team of more than 110,000 employees works across 3,700 dialysis centers and 39 manufacturing sites to deliver life‑sustaining treatments, develop advanced medical technologies and drive transformation through our FME Reignite strategy.

Within this mission, the Systems, Quality & Regulatory (SQR) organization plays a key role in ensuring product quality and safety, regulatory compliance and market access throughout the entire product lifecycle. SQR supports manufacturing and supply chain excellence, oversees post‑market surveillance, drives continuous improvement and harmonization of systems, and ensures strong data governance across Quality & Regulatory processes. Joining SQR means contributing to meaningful work that shapes the future of kidney care worldwide.

Goal of function:

The LMR & EHS Cluster Expert (CZ & SK) is responsible for implementing, maintaining and continuously improving the Global Management System (GMS), QMS and EHS frameworks within the Czech Republic and Slovakia. The role acts as a key interface between global functions, cluster leadership and local management, ensuring regulatory compliance, consistent execution of global standards and high‑quality system performance across both countries.

Some of Your responsibilities:

• Ensure implementation and adaptation of global GMS/QMS/EHS requirements into local systems in line with regulatory obligations
• Support local and cluster teams in applying assigned management systems and promote awareness of regulatory and stakeholder requirements
• Monitor and report on system performance, compliance status and improvement opportunities
• Coordinate local management reviews, follow-up actions and communication with global HQ, local teams and external certification/regulatory bodies
• Maintain and update local directives required by regulatory frameworks (e.g., EHS, Pharmacovigilance)
• Oversee training requirements, including mandatory e‑learning and system-specific training
• Evaluate compliance through KPIs, audits and gap analyses; coordinate risk assessments and corrective/preventive actions (CAPA)
• Organize annual directive reviews and support global/certification audits across the cluster
• Conduct EHS regulatory monitoring, manage EHS aspects in purchasing and coordinate EHS-related communication

Your profile:

• At least 2 - 5 years of experience in a similar position (for GMS/QMS processes)
• Bachelor’s degree in life sciences or equivalent educational background
• Training in relevant internal GMS processes and organisational structures
• Minimum of 2 years’ experience in the MedTech industry would be a strong asset
• Minimum 2 years of experience in the implementation and maintenance of management systems (QMS/GMS)
• Experience in processing documentation and controls
• Expertise in cross-functional coordination at regional level
• Experience in internal auditing and or in internal auditing processes
• Experience in cross-functional coordination at regional level
• Good knowledge of regulatory and statutory requirements with respect to medical devices (e.g. EU MDR)
• Good knowledge of applicable quality management system standards (ISO9001, ISO13485)
• Good knowledge of the applicable environmental management system standard (ISO14001), and/or FME’s related basic requirements as applicable
• High language proficiency in English (written & oral)
• Fluent in Czech and Slovak language

Our offer for you: 

• There is a lot you can discover at Fresenius Medical Care, regardless in which field you are an expert and how much experience you have -  all dedicated to your professional journey. 
• Whether in front of or behind the scenes - you are helping to make ever better medicine available to more and more people around the world 
• Individual opportunities for self-determined career planning and professional development 
• A corporate culture in which there is enough room for innovative thinking - to find the best solution together, not the quickest one 
• A large number of committed people with a wide range of skills, talents and experience 
• The benefits of a successful global corporation with the collegial culture of a medium-sized company

Feel free to submit your application directly via the following link:

👉 https://freseniusmedicalcare.wd3.myworkdayjobs.com/fme/job/CZE-Kancel-Praha---Office/Quality---Regulatory-Specialist_R0222387

We look forward to hearing from you! We would be delighted to have you join us and become part of a team that is shaping the future of healthcare.