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:
Tasks
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
Requirements
- 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)
Read Full Description