• Regulatory Affairs Associate Director, IVD

    GRAIL (Menlo Park, CA)
    …monitors and communicates changes in regulatory policies and In Vitro Diagnostic ( IVD ) requirements to project teams and leadership. They may manage and provide ... in regulatory, development, clinical affairs, quality, or program management within the IVD , medical device, or pharmaceutical industries. + Regulatory affairs and … more
    GRAIL (08/16/25)
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  • Senior Scientist, IVD Assay Verification

    Kelly Services (Sunnyvale, CA)
    …**Workplace:** Onsite in Sunnyvale, CA. **Position Title:** Senior Scientist, IVD Assay Verification **Position Type:** One-year contract **Pay rate:** $50-65 ... business by applying problem-solving skills and strategies for the verification of IVD tests on their platform. + Effectively manage experiments with shifting… more
    Kelly Services (08/28/25)
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  • Senior Scientist: IVD Assay Developer

    Nanobiosym, Inc. (Cambridge, MA)
    …or related field + Minimum of 7 years of relevant industry experience and IVD assay development + In depth knowledge and hands on experience with qPCR, sequencing ... and standard molecular biology techniques + Demonstrated technical, managerial and leadership expertise in assay development + Strong understanding of FDA and global regulatory requirements + Prefer commercial assay experience + Demonstrated experience and… more
    Nanobiosym, Inc. (09/04/25)
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  • Director Program Management (Medical Device,…

    Danaher Corporation (West Sacramento, CA)
    …At first glance, you'll see that for more than 80 years we've been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a ... team where you can be heard, be supported, and always be yourself. We're building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you'll see we are invested in you, providing the opportunity to build a… more
    Danaher Corporation (08/28/25)
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  • Regulatory Affairs Principal, IVD NPD

    Kelly Services (Sunnyvale, CA)
    …+ Prepare regulatory submissions and interacts cross-functionally to ensure OTD of product launches. + Interact with regulatory agencies/health authorities to resolve ... queries and to obtain product approvals with a focus on US and EU IVDR and WHO PQ submissions as required. + Serves as representative to gather and interpret new and changed regulations and guidelines in US and EU. + Implements continuous improvements and… more
    Kelly Services (08/16/25)
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  • Senior Biostatistician

    Danaher Corporation (Austin, TX)
    …support for clinical study design, analysis, and reporting for registration/pre-market approval (CE- IVD and US- IVD ) of qualitative and quantitative IVD ... have the opportunity to: + Provide end-to-end statistical analysis support for IVD product life cycle development through creation and verification of multiplex… more
    Danaher Corporation (09/06/25)
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  • Sales Specialist, Diagnostic Oncology (Central…

    Fujifilm (Helena, MT)
    …that community. As assigned interface with Senior Management teams from major IVD manufacturers. Maintain a comprehensive understanding of IVD reagent systems, ... with healthcare professionals and key opinion leaders for expansion of the IVD portfolio. + Display strong collaboration and teamwork skills with internal and… more
    Fujifilm (08/14/25)
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  • Specialist, Regulatory Compliance

    Danaher Corporation (Richmond, IL)
    …Leica Biosystems is responsible for working with cross-functional teams to bring IVD (In-Vitro Diagnostic), Research (RUO) and Laboratorial products to market and ... three years' equivalent experience + Minimum of two years' experience within medical device/ IVD . + FDA (Class I & II) and Health Canada regulatory knowledge… more
    Danaher Corporation (07/18/25)
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  • Division Finance Manager, US Regional Controller

    ThermoFisher Scientific (Middletown, VA)
    …Diagnostics Division (CDD) within our Specialty Diagnostics Group, provides innovative diagnostic ( IVD ) solutions for select IVD market segments and has been ... a trusted supplier in the IVD industry for over 40 years. CDD provides products...credentials and strong financial competence + Experience in the IVD or Life Sciences industry is a plus +… more
    ThermoFisher Scientific (07/08/25)
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  • Operator II, Manufacturing - 2nd Shift

    ThermoFisher Scientific (Middletown, VA)
    …The Clinical Diagnostics Division (CDD) provides innovative diagnostic solutions for select IVD market segments and has been a trusted supplier in the ... IVD industry for over 40 years. The division provides...of the world's largest suppliers of in vitro diagnostic ( IVD ) products rely on us as their OEM and… more
    ThermoFisher Scientific (09/07/25)
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