• Regulatory Affairs Manager…

    Kelly Services (Seattle, WA)
    **Kelly(R) Science & Clinical** is seeking a Sr. Regulatory Affairs Manager for a contract-to-hire position at a cutting-edge client in Seattle, WA . If ... be able to work Pacific Coast hours. The **Sr Regulatory Affairs Manager ** is responsible...expanded claims, recalls, adverse events, and impact on the IVD product and provide the appropriate data to the… more
    Kelly Services (08/08/25)
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  • Manager Quality Affairs

    Insight Global (San Diego, CA)
    …implements and documents policies and procedures within the regulatory affairs department under supervision of manager . Participates in internal initiatives ... San Diego is looking for an energetic and self-motivated Regulatory Affairs professional who will provide global... Affairs professional who will provide global regulatory expertise and strategic leadership to our IVD… more
    Insight Global (07/22/25)
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  • Manager , Global Regulatory…

    Hologic (Marlborough, MA)
    Manager , Global Regulatory Affairs ...proficiency working within a QMS. + Firm understanding of regulatory challenges in the medical device or IVD ... Marlborough, MA, United States The Manager , Global Regulatory Affairs will support leadership, ensuring alignment,...SOPs. + Deep understanding of global medical device and/or IVD regulations. + Experience managing projects in a matrixed… more
    Hologic (07/30/25)
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  • Regulatory Affairs Manager…

    Abbott (Alameda, CA)
    …work for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Regulatory Affairs Manager - APAC** position will work ... their glucose levels with our new sensing technology. This ** Regulatory Affairs Manager - APAC**... representatives, compile, prepare, and review medical device or IVD submissions to regulatory agencies in the… more
    Abbott (06/10/25)
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  • Senior Regulatory Affairs…

    Abbott (Alameda, CA)
    …diversity, working mothers, female executives, and scientists. **The Opportunity** This S **enior Regulatory Affairs Manager - APAC** position will work ... glucose levels with our new sensing technology. This **Senior Regulatory Affairs Manager - APAC**... representatives, compile, prepare, and review medical device or IVD submissions to regulatory agencies in the… more
    Abbott (06/24/25)
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  • Regulatory Affairs Manager

    ThermoFisher Scientific (Richmond, VA)
    …environment, making sure our food is safe or helping find cures for cancer. The Regulatory Affairs Manager will draft and file documentation and submission ... Collaboration** : Collaborate with R&D, PPM (product and project manager ), QA, marketing, commercial and other departments to integrate...scientific area. **Experience:** + 5 years of medical device, IVD Regulatory Affairs experience to… more
    ThermoFisher Scientific (07/26/25)
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  • Regulatory Affairs Specialist

    BioFire Diagnostics, LLC. (Salt Lake City, UT)
    …and Experience: Bachelor's Degree. Science background is preferred. 3+ years in regulatory affairs required, medical device/ IVD industry preferred. ... risks for products (for both registration and change), driving IVD (as well as RUO and Industry) products through...and labeling requirements, with some oversight from more senior regulatory specialist / manager . + May participate… more
    BioFire Diagnostics, LLC. (08/02/25)
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  • Senior Regulatory Specialist I

    Danaher Corporation (New York, NY)
    …Research Use Only (RUO) product development and sustainment. This position reports to the Senior Manager , Regulatory Affairs and is part of the Global ... Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Senior Regulatory Affairs Specialist I is responsible for… more
    Danaher Corporation (07/23/25)
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  • Senior Manager , Clinical Quality…

    Danaher Corporation (Austin, TX)
    …by the Clinical Affairs department, in addition to responses to global regulatory submissions following US and CE IVD approvals. + Evaluationof systems used ... Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Senior Manager , Clinical Quality and Compliance reporting to the Senior… more
    Danaher Corporation (07/25/25)
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  • Director R&D - Clinical Assay/CDx Development

    BD (Becton, Dickinson and Company) (San Diego, CA)
    …activities. By working successfully across functions-including Program Management, Marketing, Regulatory , Quality, and Medical Affairs -this leader will ensure ... activities. By working successfully across functions-including Program Management, Marketing, Regulatory , Quality, and Medical Affairs -this leader will ensure… more
    BD (Becton, Dickinson and Company) (07/30/25)
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