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Fresenius Kabi Deutschland GmbH

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Senior Manager Medical Device Project Lead (m/f/d)
Eysins (Schweiz)
Aktualität: 10.05.2021


10.05.2021, Fresenius Kabi
Eysins (Schweiz)
Senior Manager Medical Device Project Lead (m/f/d)
Manage all device development activities from concept to launch in compliance with FDA CFR, ISO 13485 and company's QMS. Lead the design, development, testing, verification and validation activities with external partners. Author and manage the preparation of quality documents required for a DHF in compliance with SOPs and industry standards. Prepare and support the device section for the regulatory submission BLA and MAA of drug/device combination products. Define and manage the detailed device development plan, risk management plan, verification & validation plan and usability engineering plan. Deliver device and packaging & labelling according to plan and budget and coordinate the tech transfer to a production unit. Tightly control device development timelines, budget and risks. Act as the main interface between the biosimilars project development teams and the sub teams (e.g. medical devices, manufacturing & supply, etc.) as well as device vendors. Provide clear and timely communication to biosimilars project development team and management. Provide technical and business inputs to projects. Proactively anticipate and identify risk areas and alert stakeholders appropriately. Report and escalate to management potential issues as needed.
Bachelor's degree (or equivalent) in an applicable Product design, Mechanical, Process, Materials Science or Electronic Engineering field. Deep knowledge of ISO standards including ISO 13485, ISO 14971 and ISO 11608 as well as FDA 21 CFR Part 820. Excellent technical understanding of device design, verification, validation, manufacturing and their link to other drug development activities (clinical, manufacturing, commercial, etc.). 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. 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. Experience in FDA regulated medical devices, Standalone CE marked devices and combination drug device products.