• Senior Process Engineer

    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
    Danaher Corporation (06/26/25)
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  • Clinical Affairs Associate - IVD

    ThermoFisher Scientific (Carlsbad, CA)
    …Chemistry, bio-engineering or related science. **Experience** + 3+ years experience in the In Vitro Diagnostic , Medical Device Industry or similar. + 3+ years of ... on ensuring that both internal and external projects for advancing our in vitro diagnostics adhere to Good Clinical Practice (GCP) and relevant regulatory standards… more
    ThermoFisher Scientific (08/01/25)
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  • Staff Program Manager (Operations Strategy,…

    Danaher Corporation (Sunnyvale, CA)
    …and completion of Operations programs within a medical device and/or molecular in- vitro diagnostic company while ensuring consistency with company strategy, ... or DBS certification is highly preferred. + Medical device and/or In Vitro Diagnostic product experience. + Business solutions implementation experience.… more
    Danaher Corporation (08/08/25)
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  • Clinical Research Regulatory Affairs Manager

    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
    Kelly Services (08/26/25)
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  • Senior Quality Systems Specialist

    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 (08/16/25)
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  • Senior Clinical Research Scientist

    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 (06/11/25)
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  • Quality Systems Specialist III

    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 ... At Cepheid, we are passionate about improving health care through fast, accurate, molecular diagnostic systems and tests. As a member of our team, you'll get to make… more
    Danaher Corporation (08/26/25)
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  • Labeling Specialist (Med Device)

    Actalent (San Diego, CA)
    …Labeling Specialist to oversee the labeling process for both new and existing In Vitro Diagnostic (IVD) and Medical Device (MD) products. This role requires ... cross-functional coordination and a strong understanding of regulatory standards to ensure all labeling materials meet specifications and compliance requirements.  Key Responsibilities: + Lead the development and revision of product labeling, including… more
    Actalent (08/23/25)
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  • Director Infusion Systems

    BD (Becton, Dickinson and Company) (San Diego, CA)
    …10 years of directly related Regulatory Affairs experience in medical devices and/or in vitro diagnostic field + Minimum of 7 years of personnel management ... (direct report) experience including performance evaluations/improvement, and career development + Software experience including SaMD/SiMD is a plus + Regulatory and Quality Information Management systems such as SAP, RIM, or related systems + Digital literacy… more
    BD (Becton, Dickinson and Company) (08/22/25)
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  • Quality Engineer II

    Abbott (Alameda, CA)
    …action of medical devices, including software as a medical device (SaMD), in- vitro , diagnostic devices, consumer devices, and accessories. **What You'll Work ... On** + Lead/support design planning efforts to include heading cross-functional teams; establishing deliverables and tracking completion for complex projects + Lead/support complex investigations and CAPA activities + Drives alignment in cross functional… more
    Abbott (08/21/25)
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