• Diagnostic Regulatory…

    Astellas Pharma (Northbrook, IL)
    …selection and stratification in clinical studies across all phases of drug development. As a Diagnostic Regulatory Strategy Lead , you will be the primary ... and late-stage drug programs. + Provide expert guidance on diagnostic regulatory pathways including IVDR (EU), FDA...mitigations + Lead and/or support preparation of diagnostic related regulatory submissions including IVDR clinical… more
    Astellas Pharma (10/12/25)
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  • Senior Principal Scientist - Global…

    Amgen (Washington, DC)
    …a biomarker assay to marketed Diagnostic to support the clinical development strategy for regulatory approval and commercialization. As such, the Dx group ... support therapeutic product teams, including regulatory approval, commercialization, and diagnostic lifecycle plans + Lead efforts to oversee assay… more
    Amgen (08/09/25)
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  • Senior Director Algorithms - Diagnostic…

    GE HealthCare (Waukesha, WI)
    …the development and lifecycle management** of a diverse portfolio of diagnostic cardiology algorithms, ensuring regulatory compliance, clinical efficacy, and ... This Senior Director role reports to the CTO for Diagnostic Cardiology (DCAR) and is responsible for defining and...for GE HealthCare internal and external stakeholders. You will lead a team of high-performing technologists and clinical experts… more
    GE HealthCare (10/15/25)
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  • Manager II, Lab Planning & Operations,…

    Bristol Myers Squibb (Princeton, NJ)
    …ensuring robustness and compliance across assay design, validation, and transfer. + Lead complementary diagnostic efforts using NGS, PCR, and flow cytometry ... & Operations will provide leadership and operational oversight for companion diagnostic (CDx) assay design, development, and clinical testing in a CLIA-certified… more
    Bristol Myers Squibb (10/25/25)
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  • Global Regulatory Affairs Device…

    Sanofi Group (Morristown, NJ)
    … impact assessments for proposed product changes + May serve as a regional/local regulatory lead and point of contact with medical deviceHealth Authorities for ... Diligence activities as applicable May serve as Device Global Regulatory Lead (dGRL) leading a Device GRT,...prioritization, objectives and setting clear expectations for the device regulatory strategy , including a global labeling … more
    Sanofi Group (10/23/25)
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  • Medical Director, Diagnostic Cardiology

    GE HealthCare (Waukesha, WI)
    … submissions, and marketing, based on intended clinical applications, business, and regulatory strategy + Establish and cultivate strategic academic partners ... and national meetings of professional societies + Manage medical materials for regulatory , marketing, and commercial activities + Lead medical reviews of… more
    GE HealthCare (10/28/25)
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  • Program Director - Diagnostic Cardiology

    GE HealthCare (Waukesha, WI)
    …driving the successful execution of New Product Introductions (NPIs) in the Diagnostic Cardiology business of GE HealthCare. This strategic leader defines and ... the timely delivery of innovative, high-quality products and solutions for the diagnostic electrocardiography (ECG) business. As the leader of the Program Management… more
    GE HealthCare (08/21/25)
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  • Project Manager - Diagnostic Solutions

    BD (Becton, Dickinson and Company) (Sparks, MD)
    …through project transition. The Customer Experience Management is key to the success of Diagnostic Solutions strategy and is required to drive a high level of ... a **maker of possible** with us. **JOB SUMMARY:** The Project Manager - Diagnostic Solutions, is responsible for the full Implementation Cycles associated with the… more
    BD (Becton, Dickinson and Company) (10/18/25)
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  • Director, Regulatory Affairs, Dx/CDx…

    BeOne Medicines (Emeryville, CA)
    …will be responsible for leading a small team for developing and implementing regulatory diagnostic and medical device strategies as applicable, for the ... stakeholders. **Essential** **Functions** **of** **the** **job:** + Develop European and/or UK regulatory strategy for the designated program, and contribute to… more
    BeOne Medicines (10/12/25)
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  • Director, Early Precision Medicine…

    Bristol Myers Squibb (Princeton, NJ)
    …or Madison, New Jersey **Position Summary** The Director of Early Precision Medicine Regulatory Affairs leads global regulatory strategy for biomarkers and ... with business needs and enabling timely, compliant submissions + Serve as the regulatory lead on the Translational Medicine CLIA Laboratory Steering Committee,… more
    Bristol Myers Squibb (10/29/25)
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