• Clinical Affairs Associate - IVD

    ThermoFisher Scientific (Carlsbad, CA)
    …demonstrated experience leading in house and/or external clinical studies. + CDx/ IVD clinical experience desired. + Veeva Vault/eTMF, Medrio/EDC experience desired. ... **Knowledge, Skills and Abilities** + Working knowledge of Good Clinical Practices. + CCRP certification or coursework in Good Clinical Practices. + Experience with multi-functional project teams. + Computer literacy in spreadsheets, databases, and word… more
    ThermoFisher Scientific (08/01/25)
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  • Senior Quality Specialist, IVD

    Kelly Services (Sunnyvale, CA)
    …The **_Sr. Quality Specialist_** is responsible for supporting quality systems activities related to assay development, especially, design control and risk management ... activities in accordance with FDA and ISO regulations. This position is part of the Product Lifecyle Quality group in R&D and reports to the Sr. Manager, Product Lifecyle Quality and will be onsite based, located in **Sunnyvale, California.**… more
    Kelly Services (07/29/25)
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  • Manager Quality Affairs

    Insight Global (San Diego, CA)
    …who will provide global regulatory expertise and strategic leadership to our IVD product development teams. This position is focused on pre-market development ... role also offers the opportunity to work alongside the IVD Quality team in the development and implementation of...members to maximize chances for first pass approval of IVD regulatory submissions, compliant with the appropriate regional or… more
    Insight Global (07/22/25)
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  • Sales Specialist, Diagnostic Oncology (West Coast)

    Fujifilm (Sacramento, CA)
    …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 (08/03/25)
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  • Division Finance Manager, US Regional Controller

    ThermoFisher Scientific (Fremont, CA)
    …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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  • Program Manager

    BD (Becton, Dickinson and Company) (San Diego, CA)
    …Degree or equivalent + PMP Certification + Proficient understanding of IVD Medical Device Regulations, Product Development Process, and Operations + Demonstrated ... track record of successfully managing and leading projects in the medical device/ IVD industry. + Experience with reagent manufacturing or lifecycle management in a… more
    BD (Becton, Dickinson and Company) (08/03/25)
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  • Regulatory Affairs Process Specialist

    Kelly Services (Sunnyvale, CA)
    …authorities. + Update FDA establishment registrations and device listings for IVD products. + Maintain and administrate regulatory dossier management system. + ... Assign GMDN and UDI (GTIN) codes to IVD products. + Maintain and administrate UDI Management software...lines or manufacturing processes either for Med device or IVD products + Prior knowledge of different databases like… more
    Kelly Services (07/24/25)
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  • Director R&D - Clinical Assay/CDx Development

    BD (Becton, Dickinson and Company) (San Diego, CA)
    …regulatory bodies. + Understanding of regulations, standards and guidelines related to IVD , and/or medical devices and quality systems including 21 CFR, CE- IVD ... , ISO 13485, etc. **Why Join Us?** A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we… more
    BD (Becton, Dickinson and Company) (07/30/25)
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  • Quality Engineer, Product Design

    Hologic (San Diego, CA)
    …related to Design Control efforts in accordance with FDA, ISO, and other IVD regulations. You will also support the company's quality system activities and design ... control/quality product design experience in a regulated environment, ideally in the IVD space. + Working knowledge of Quality Management System for Medical Device… more
    Hologic (07/03/25)
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  • Associate Client Advocate - Commercial Insurance…

    WTW (Los Angeles, CA)
    …and Client Advocate within our Retail & Distribution Industry Vertical Division ( IVD ). The Associate Client Advocate (ACA) owns client service activities and client ... mentor to other ACAs, a partner/ team member for others within your IVD , or an ACA Leader. Note: Employment-based non-immigrant visa sponsorship and/or assistance is… more
    WTW (07/03/25)
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