- Bayer (Cambridge, MA)
- …& Gene Therapy (CGT) but also for other precision medicine programs with in vitro diagnostic (IVD), companion or complementary diagnostic (CDx) component, ... with diagnostic co-development partners and leads the development of diagnostic regulatory strategy in multiple projects in clinical development and marketing… more
- Danaher Corporation (West Sacramento, CA)
- …part of a multifunctional team and drive to root cause for manufacturing of in- vitro diagnostic consumables. + Lead projects to assess risk (pFMEAs), perform ... validations (equipment, process, software), and implement process changes for manufacturing of in- vitro diagnostic consumables. + Lead or participate in cross… more
- BD (Becton, Dickinson and Company) (Durham, NC)
- …preferred + Minimum 5 years of Regulatory Affairs experience in medical device or in vitro diagnostic device companies or 3 years of experience with an advanced ... in negotiating with regulatory authority personnel in medical device and in vitro diagnostic areas + International product registration experience preferred… more
- Kelly Services (Sunnyvale, CA)
- …and overseeing the translation of customer-facing documents for our client's in vitro diagnostic tests and instrument systems. Document types include ... guidelines, and regulations governing the development, documentation, and labeling of in vitro diagnostic products. + Strong verbal communication skills for… more
- Kelly Services (South San Francisco, CA)
- …position is focused on pre-market development activities with a key focus on in vitro diagnostic systems including assay, software and hardware. This role also ... + Solid working knowledge of global regulatory requirements related to in- vitro diagnostics systems, laboratory automation and software / hardware components of… more
- Danaher Corporation (Sunnyvale, CA)
- …groups to design, refine, and test various instrument components/systems for in vitro diagnostic projects. The R&D Systems Engineer is responsible for ... are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of...Together, we're working at the pace of change on diagnostic tools that address the world's biggest health challenges,… more
- Danaher Corporation (Bothell, WA)
- …of synthetic oligonucleotides under a cGMP environment for use in Cepheid in- vitro diagnostic products. The Laboratory Technician will use scientific knowledge ... are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of...Together, we're working at the pace of change on diagnostic tools that address the world's biggest health challenges,… more
- Danaher Corporation (Sunnyvale, CA)
- …and/or Human Physiology with related work experience. + Experience with in vitro diagnostic (IVD) products, preferably in molecular diagnostics or ... are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of...Together, we're working at the pace of change on diagnostic tools that address the world's biggest health challenges,… more
- Danaher Corporation (Sunnyvale, CA)
- …compliance with Food & Drug Administration (FDA), ISO 13485, European Union In Vitro Diagnostic Regulation (IVDR) as well as other applicable global regulatory ... are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of...Together, we're working at the pace of change on diagnostic tools that address the world's biggest health challenges,… more
- Danaher Corporation (Sunnyvale, CA)
- …Operator's Manuals/User's Guide, and Getting Started Guides) for Cepheid's menu of in vitro diagnostic products. This is an on-site position within the Technical ... passionate about improving health care through fast, accurate, molecular diagnostic systems and tests. As a member of our...is to be the leading provider of seamlessly connected diagnostic solutions. In this role, you will have the… more
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