The Senior Manager, Regulatory Affairs position will support the Regulatory Affairs (RA) Director to help define the regulatory strategy for our innovative next generation technology for cellular therapy. This position will play a substantial role researching regulations, defining and implementing the regulatory strategy and engaging with health authorities to effectively

This position will be responsible for Supplier Quality in the Production Unit (PU). This position will ensure compliance to quality system requirements and drive the highest quality standards by helping to define specifications and by collaborating with suppliers. This role requires working in a cross functional team environment with members of the R&D Design Centers, for

Act as the primary contact for Warrendale Service Depot, supporting the Medical Device business. Accurate data entry of LVP service orders, initiation of Debt Memo request and APRISO work orders. Responsibilities Create SAP service orders for the LVP Service Depot, and initiate Debt memos Identify and report potential complaints per criteria on service orders. Assist in m

This position performs primary notification and is a consolidation point for receiving and processing basic complaint investigation activities. The position ensures timely and accurate investigation of customer complaints to help ensure Fresenius Kabi complies with all regulatory obligations and meets the customers' needs. Responsibilities Perform complaint investigation

This position performs primary notification and is a consolidation point for receiving and processing basic complaint investigation activities. The position ensures timely and accurate investigation of customer complaints to help Fresenius Kabi comply with all regulatory obligations while meeting the customers' needs. Responsibilities Capture all complaint information and

Under direct supervision, provide clerical and administrative support for documentation system under cGMP and support the Quality System. Issue and control documents according to established procedures. Administer document routing and review process. Research and collate file records as needed. May also operate a desktop computer using word processing software. Fill docum

The Plasma Services Consultant is responsible for providing technical and operator l product and sales support for customer organizations within an assigned territory in US. Act as key customer liaison and consultant managing both customer and company needs. Assist in process and operational improvements within a customer center and ensures that customers are properly tra

The Manufacturing Technician II is responsible for effectively troubleshooting the cause of manufacturing non conformances of in process medical devices and making the required repair in accordance with manufacturing procedures. The position includes performing testing, sorting, and rework of non conforming parts found in manufacturing or at receiving inspection. Other re