• 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 Specialist

    BioFire Diagnostics, LLC. (Salt Lake City, UT)
    …assessing regulatory risks for products (for both registration and change), driving IVD (as well as RUO and Industry) products through government/regulatory approval ... Science background is preferred. 3+ years in regulatory affairs required, medical device/ IVD industry preferred. Knowledge, Skills and Abilities: + Knowledge of MD/… more
    BioFire Diagnostics, LLC. (08/02/25)
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  • Associate Director, Precision Medicine…

    Regeneron Pharmaceuticals (Armonk, NY)
    …expected to manage and deliver the execution of diagnostic projects (CDx, IVD , etc.) within Regeneron's drug development pipeline in partnership with Diagnostic ... Strategy Leads and IVD Regulatory Affairs. This is a leadership role within...must have strong expertise in drug development planning and CDx/ IVD development with pharmaceutical companies. **This role might be… more
    Regeneron Pharmaceuticals (07/26/25)
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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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  • Senior Regulatory Specialist I

    Danaher Corporation (New York, NY)
    …closely with the cross-functional design and development team to support both IVD medical device and Research Use Only (RUO) product development and sustainment. ... marketing materials, and product changes to ensure compliance across IVD and RUO products. + Collaborate cross-functionally with global...job include: + 5+ years of regulatory experience in IVD medical devices, with a Bachelor's, Master's, or PhD,… more
    Danaher Corporation (07/23/25)
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  • Sr. Manager QC

    ThermoFisher Scientific (Middletown, VA)
    …Information** 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 (07/19/25)
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  • Manager Quality Assurance

    Abbott (Abbott Park, IL)
    …controls and risk management, as well as an understanding of the US IVD regulatory submissions process and required contents. The candidate must have experience in ... and responsibilities expected of this position include providing support for US IVD product submission reviews, and consultation in matters of Quality System and… more
    Abbott (07/03/25)
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  • Director, Precision Medicine, Companion…

    Regeneron Pharmaceuticals (Armonk, NY)
    …study conduct, sample management testing to launch) in collaboration with partners/ IVD Sponsors and central testing laboratories to support early and late-stage ... all of the relevant inputs + Develop strong relationships partnerships with IVD partners and testing laboratories + Oversee operational aspects of CDx clinical… more
    Regeneron Pharmaceuticals (06/20/25)
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  • Formulation Technician II - 3rd 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 (05/22/25)
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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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