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Senior Director Medical Device Program Lead (m/f/d)
Eysins (Schweiz)
Aktualität: 22.09.2021


22.09.2021, Fresenius Kabi
Eysins (Schweiz)
Senior Director Medical Device Program Lead (m/f/d)
Lead a team of cross functional device experts including Device project leads, Human Factor and Risk Management,... Lead definition of device development strategy in partnership with key internal stakeholders. Ensure implementation of Quality Management System within Fresenius Kabi SwissBioSim Lead cross-functional exercises to define targeted device profiles. Develop device development project plans and budget with internal and external cross functional teams. Deliver quality products and processes with appropriate validation and regulatory documentation. Report and tightly control device development timelines, budget and risks to biosimilars project development team. Act as the main interface between the biosimilars project development teams and the subteams (e.g. medical devices, manufacturing & supply, etc.) as well as device vendors. Provide technical and business inputs to projects. Analyze risks and suggest mitigation plans. Oversee device development, manufacturing, validation and regulatory activities. Proactively anticipate and identify risk areas and alert stakeholders appropriately. Report and escalate to management potential issues as needed. Identify new device opportunities
Bachelor's degree (or equivalent) in an applicable Product design, Mechanical, Process, Materials Science or Electronic Engineering field. 5+ years of experience in project management 10+ years of experience in device development with an understanding of device safety, regulatory requirements, policies and procedures. Deep technical understanding of device design, validation, verification and their link to other drug development activities (clinical, manufacturing, commercial, etc.) in the overall drug development plan. Experience in FDA regulated medical devices, Standalone CE marked devices and combination drug device products. Track record of resolving issues in a matrix organization. Strong interpersonal and relationship building skills with the ability to establish a trusted role with the various stakeholders. Solid organizational skills including attention to detail and multi-tasking skills. Effective verbal and written communication. Fluent in English, both oral and written; additional languages (German or French) are an asset. Managerial experience



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