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Archiviertes Projekt - Medical Device Project Leader

Mai 2019

Dezember 2019

CH-Großraum Basel

auf Anfrage



The successful candidate for this position will need to be able to lead the technical development of packaging and/or drug delivery systems within the Packaging & Device Development Team, from early phase activities up to commercialization and production scale up. In addition to outstanding project management and inter-personal skills, a strong technical background in medical devices and in pharmaceutical packaging development is crucial to support, monitor and challenge internal and external development partners.

Tasks and responsibilities would typically include:
• *Thorough project planning*
• Leading the definition of product requirements for packaging, medical devices, delivery systems, e.g. drug/device combination products in which the device is generally already registered but sometimes to be developed
-• *Provide primary packaging and device expertise in a broader cross-functional drug product development team*
• • *Leading Risk management activities*
• *Planning and monitoring of design verification activities (in-house)*
• *Leading and authoring technical documentation*
• *Ensuring a high quality Design History file*
• *Transfer of Design History File to production*

Experience desired
• Good understanding of pharmaceutical development in general
• Experience in project / program management of complex projects
• *Understanding of medical device regulations (FDA 21CFR 820, FDA 21CFR Part 4, EU Medical Device Directive, EU Medical Device Regulation)*
• *Development and writing of technical documentation of drug/device combination products and medical devices, including Design Control process and other applicable regulatory, QA and GMP aspects*


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