Fresenius Medical Care is the world’s leading provider of products and services for dialysis 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.
Our manufacturing plant in Palazzo Pignano specializes in producing bloodlines, operating around the clock with a dedicated workforce of more than 550 employees. Within this dynamic setting, we are looking for a member of IC Value Stream (VS) Interface department with following deliverables:
Overall responsibility (per product group):
Member of the global VS Interface organization enabling proper projects execution and managing products life cycle across all global markets.
Establish efficient and effective interfaces with VS and other involved departments to assure fast global market access.
Oversee the capacity management and prioritization of VS Interface activities in line with the In Center Strategic priorities.
Develop, deploy and monitor performance to VS Interface KPIs (Key Performance Indicators).
Ensure external regulatory intelligence, from the medical device market and regulatory authorities, is understood and translated into Fresenius processes and products as required.
Communicate/collaborate to ensure VS Interface is a trusted partner with all relevant functions within Fresenius to achieve effective Regulatory compliance and patient/product outcomes (Q&R departments, Value Streams, SYSQARA Regulatory Affairs and Registration Centers of Verticals Home and CC&V, Commercial Teams, Medical Affairs)
Develop and foster a culture of continuous improvement and process optimization, sharing best practices across global departments and Care Enablement.
Monitor, report and react to regulatory compliance, covering the full In Center product portfolio, active and non-active medical devices and products.
Establish standardized global VS expectations as input to product development / improvement strategies, sustaining development project teams.
Support and provide information to other Care Enablement departments.
Support the implementation and maintenance of regulatory information management system and provide input.
Work with relevant stakeholders in the organization to create and maintain a harmonized document management structure for regulatory relevant documents across all products groups, based on a global system.
Q&R representative (per product group):
Member of Cross Functional Team (CFT) as representative of Q&R.
Business Review Representative of Q&R.
Attendance to Project Governance Meetings (HD):
Release Governance Meeting
Project Review Meeting
Portfolio Synch Meeting
Document Approvals for:
Milestone Approval
Quality Holds
Representative of Q&R in IC meeting like:
Business Reviews
Major Quality Issue (MQI) Meetings
Monthly CAPA (QARA)
Local/regional Q-Meetings (CAPA, CMP, Technical Operations, PQTF, performance trending/monitoring)
PSC
Responsable Product Center role:
Deputy of the Product Center Responsible (PCR) for a specific product group.
Interface to Manufacturing and Supply Chain Network functions.
Support, as applicable, digitalization projects and all related activities (validation, cybersecurity, data integrity and data protection, etc.)
Support global external agency audits e.g., by FDA, NMPA, INMETRO and audits by Notified Body
Technical/Engineering/Scientific background
5+ years professional experience in the field of Regulatory or Quality Assurance Medical Devices / Medicinal Products
Knowledge in the field of development and/or manufacture and control of Medical Devices and Medicinal Products
Advanced knowledge of applicable quality management and of risk management standards (e.g. ISO13485, ISO14971, EU Guidelines for GMP, IFDA 21 CDR §820.250, etc.)
Advanced knowledge of medical device regulations (MDD 93/42/EEC, MDR 2017/745, etc.)
Knowledge of internal and external processes and structures and of the Quality Management System requirements
Experience in project management
English (fluent, good knowledge)
Finché l'annuncio di lavoro sarà disponibile, potrai candidarti in maniera semplice e rapida.
Ci preoccupiamo di condividere informazioni ed esperienze in quanto ciò ci aiuta a imparare dai nostri errori e gli uni dagli altri. Affrontiamo insieme le sfide contattando i colleghi vicini e lontani. Comunichiamo apertamente.
Sfidiamo lo status quo e mostriamo interesse per ciò che accade intorno a noi. Facciamo domande per capire chiaramente cosa deve essere fatto e assumerci la responsabilità dei risultati.
Siamo all'altezza delle nostre aspettative, mostriamo rispetto e diamo l'esempio. Ogni giorno agiamo con integrità e in linea con i nostri standard.
Rendiamo le cose migliori oggi rispetto a ieri. Proponiamo idee su come migliorare e innovare.
Potenziare le persone. Cura avanzata. Ispirando con il nostro scopo e valori.
Tutto ciò che facciamo qui mira a rendere la vita delle persone migliore, più semplice e più lunga. I nostri team lavorano in modo interfunzionale per riprodurre la complessa funzione dei reni con trattamenti che soddisfano standard di qualità elevati, migliorano i risultati clinici e sono sostenibili e conformi. Internamente, promuoviamo la diversità e l'inclusione come elementi chiave di un ambiente di lavoro positivo e di supporto. I nostri valori supportano la nostra missione di sviluppare prodotti e servizi di alta qualità, avere un impatto positivo sulla salute e sul benessere dei pazienti e guidare Fresenius Medical Care verso un futuro di successo e sostenibile.