LMR & EHS Cluster Expert (Czech and Slovakia)

At Fresenius Medical Carewerededicated to improving the lives of patients with chronic kidney disease through innovative high-quality products and treatments. Our visionCreating a future worth living. For patients. Worldwide. Every day.guides everything we do. With over110000 peopleworking across 3700 dialysis centers and 39 manufacturing sites worldwide we provide direct patient care through our Care Delivery network develop and supply medical products therapies digital solutions via Care Enablement and accelerate transformation through our FME Reignite strategy. Our values drive us:

• We Carefor our patients each other and our communities.

• We Connectacross teams and borders to deliver excellence together.

• Andwe Committo doing things the right way growing with purpose and leading kidney care with innovation and compassion.

As part of this commitment Systems Quality & Regulatory (SQR)a global function within Care Enablementensures product quality and safety regulatory compliance and market access throughout the entire product lifecycle. The team drives quality across manufacturing and supply chain processes manages post-market surveillance and promotes continuous improvement system harmonization and sustainability. SQR also oversees Q&R data governance and delivers key product-related business services. Join our passionate team and help shape healthcare worldwide!

Goal of function:

The LMR Cluster Expert function is responsible to ensure:

• The implementation maintenance and continual improvement of the Global Management System (GMS) GMS BasicSystemand the applicable specific management systems according to global requirements and in compliance with local regulatory and statutory requirements.

• To act asinterfacebetween Global functions ClusterLeadand local Management with regards to GMS and applicable regulatory requirements.

• This roleis responsible forQMS and EHS for a cluster of countries (Czech and Slovakia) within EMEA and ensures consistent high-quality implementation and execution of QMS and EHS requirements and guidelines across the countries under the respective responsibility.

Some ofYour responsibilities:

• Ensuring the adaptation of the applicable global requirements into the local system to achieve bestpossible resultsof the practical operations and ensuring regulatory and statutory compliance

• Supporting responsible functions at local and clusterlevelin the implementation of the assigned management systems.

• Ensuring the promotion of awareness of regulatorystatutoryand respective stakeholder requirements at local and clusterlevel.

• Reporting on the status of the assigned management systems theirperformanceand opportunities for improvement.

• Coordinating the local management review and reporting to local managementincludingthe follow-up of decisions and resulting action items as.

• Acting as interface with global HQ functions local functions and external certification and regulatory bodies within the cluster in scope.

• Ensuring thatadditionalneeded local directives in the respectivescopeareestablished implementedmaintainedand improved. (Implementation includes directives that areadditionalto the established management system(s) that are required due to regulatory requirements.: Pharmacovigilance or EHS Regulatory related Directives for the cluster)

• Ensuring training organization and realization in coordination with local responsible training functionsEnsuringthat mandatory e-learning training and requirements are in place in the global Compliance Wire or other E-learning tools as applicable. (e.g.mandatory training of LMR implementation of QRIS).

• Reviewing compliance of the local organization with requirements of the assigned local management systems (e.g.by evaluation of KPIs by audits) of the countries from the cluster in scope.

• Coordinating gapanalysis checkof applicability and process risk assessment before their implementation into the local management system(s) of the cluster together with local experts (e.g.identification of control measures).

• Organizing annual directives review together with the process owners tomaintain update correctGMS locally for all the countries within the scope of the respective cluster.

• Coordinating annual global audits including audits by certified bodiesi.e.coordination of audit schedule and planorganizeon-site visits with the applicable global department.Maintaining system applicable data (e.g. registrationof units change notification to global function/ notified/ certification body).

• Ensuring thatappropriate improvementmeasures (e.g.corrective action/ preventive action/ CAPA) are performed asProvidingconsultancy for local process owners on the identification of root-causes and performance of corrective action/CAPA related toidentifiedrisk cases (e.g.product re-calls).

• Coordinating with applicable global department for activities related to external audits andsubsequentidentified improvement actions (e.g.notified bodies authorities).

• Conducting or coordinating EHS communication (interface to EHS System team in case of tender/customer requests with Global/Product relevance)

• Coordinating annual declaration of EHS compliance of local operations by responsible local CE management

• Carrying out regulatory monitoring of local applicable EHS regulations (monitoring evaluation registration communication)Managing EHS related aspects for purchasing

Your profile:

• At least 2 - 5 years of experience in a similar position (for GMS/QMS processes)

• Bachelors degree in life sciences or equivalent educational background

• Training in relevant internal GMS processes andorganisationalstructures

• Minimum of 2 years experience in the MedTech industrywould 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

• Expertisein 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 FMEs related basic requirements as applicable
• High language proficiency inEnglish (written & oral)
• Fluent in Czech and Slovak language

Our Offer for you:

There is a lot you can discover at Fresenius Medical Care regardlessinwhich field you are an expert and how much experience you have- alldedicated to your professional journey.

• Whether in front of or behind the scenes - you are helping to make ever better medicine available tomore and morepeople 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 ofcommitted people with a wide range of skillstalentsand experience

• The benefits of a successful global corporation with the collegial culture of a medium-sized company