- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …design control, market and product requirements management, and the IVD development process preferredKnowledge of molecular diagnostics technology, competitors, and ... market space preferredEstablished expertise and hands-on experience with Microsoft Project, Word, Excel, PowerPoint, Outlook, SharePoint and remote meeting tools such as MS Teams, WebEx, Live Meeting preferredExpert planning and tracking skills, with the… more
- BioFire Diagnostics, LLC. (San Jose, CA)
- …well as in production. The position requires knowledge of FDA regulatory processes for IVD products. Primary Duties: + Manage and mentor a small group of data ... of multi-modal signal analysis + 5+ yrs of professional experience in development of IVD products in a regulated environment + 3+ yrs of prior team management… more
- GRAIL (Durham, NC)
- …partnerships with pharmaceutical companies for companion diagnostic (CDx) tests. The Associate Director will work cross-functionally to manage Grail's Clinical ... as they relate to clinical trial conductUnderstanding of appropriate global medical device/ IVD requirements, such as: ICH E6 (GCP), European Union (ISO 20916, ISO… more
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- …proven experience with application of quality and regulatory requirements for IVD manufacturers in the design and development of medical devices. listings, ... establishment registrations, etc. is a must. + Proven knowledge of international regulations for product registration. Experience in preparation of EU Technical Dossier, STED documentation, etc. + Excellent project management, negotiation, communication… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …of design control, market and product requirements management, and the IVD development process preferred + Knowledge of molecular diagnostics technology, ... competitors, and market space preferred + Established expertise and hands-on experience with Microsoft Project, Word, Excel, PowerPoint, Outlook, SharePoint and remote meeting tools such as MS Teams, WebEx, Live Meeting preferred + Expert planning and tracking… more
- BioFire Diagnostics, LLC. (Hazelwood, MO)
- …activities. Primary Responsibilities: + Lead team of 190+ people in a 24/5 IVD medical device production environment. + Oversee day to day operations of the ... manufacturing department that include scheduling, production planning and resource allocation. + Lead the team by example and maintain moral of the work force and address personnel issues. + Communicate with Shift Managers to ensure a cohesive product flow. +… more
- Interstate Blood Bank (Vista, CA)
- …inventory to maximize value generation for the business unit + Collaborate with Associate Director , Donor Centers Operations and Director RUO Laboratory ... Biology, or similar. + 3-4 years of experience in IVD field in R&D assay technical support or any...an equivalency could include 8 years of experience, an Associate 's degree with 6 years of experience, or a… more
