• Regulatory Affairs Manager, Diagnostics/…

    Kelly Services (Seattle, WA)
    …new or revised standards, expanded claims, recalls, adverse events, and impact on the IVD product and provide the appropriate data to the Project Lead to prepare ... regulatory bodies is highly preferred. . Experience with US and international IVD regulations . Broad knowledge of post market surveillance regulations, practices,… more
    Kelly Services (08/08/25)
    - Related Jobs

  • 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)
    - Related Jobs

  • Sr. Manager, Strategic Partnerships ( IVD…

    Danaher Corporation (Marlborough, MA)
    …It would be a plus if you also possess previous experience in: + IVD and Proteomics Platforms + Working with US pharmaceutical, biotech, and leading academic ... customers + Selling complex solutions and services associated with traditional proteomics applications At Abcam we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles… more
    Danaher Corporation (07/11/25)
    - Related Jobs

  • 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. (06/05/25)
    - Related Jobs

  • 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)
    - Related Jobs

  • 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)
    - Related Jobs

  • Sales Specialist, Diagnostic Oncology (West Coast)

    Fujifilm (Pierre, SD)
    …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)
    - Related Jobs

  • 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)
    - Related Jobs

  • 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)
    - Related Jobs

  • 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 (08/08/25)
    - Related Jobs