• Director, Submission Operations Management

    BeOne Medicines (Emeryville, CA)
    systems configuration decisions. + Manage business processes, operations, and updates for all Regulatory systems to support internal customer needs. + ... and IT business partners to ensure effective communication and efficient management of regulatory technology and systems , as well as processes, as outlined… more
    BeOne Medicines (08/01/25)
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  • IT Business Analyst - Regulatory

    Danaher Corporation (Brea, CA)
    …in global safety data and content authoring software solutions (ie UL WERCS Studio) and regulatory information systems . It would be a plus if you also possess ... world, more than one million tests are run on Beckman Coulter Diagnostics systems , impacting 1.2 billion patients and more than three million clinicians per year.… more
    Danaher Corporation (07/26/25)
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  • R&D Electrical Engineer

    J&J Family of Companies (Irvine, CA)
    …prototypes and production units + Collaborate with cross-functional teams (mechanical, software, systems , regulatory ) to support product development and ... and analyze electrical schematics and PCB layouts with minimal supervision + Support design, development, and testing of analog and digital electronic circuits for… more
    J&J Family of Companies (08/08/25)
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  • Clinical Research Regulatory Specialist

    University of Southern California (Los Angeles, CA)
    …investigators and quality assurance systems for the Clinical Investigations Support Office. Provides regulatory affairs support , coordinating or ... equipment receipts, investigation logs, etc. Reviews documentation as needed to support regulatory filings, and maintains research files and documentation… more
    University of Southern California (07/11/25)
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  • Regulatory Affairs Specialist II - Ventures…

    Abbott (Santa Clara, CA)
    …and approving requests for product release. + Reviews protocols and reports to support regulatory submissions. + Supports all business segment initiatives as ... comply with regulatory agency specifications. This new team member will support necessary regulatory activities required for clinical trial operations and… more
    Abbott (05/17/25)
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  • Principal Regulatory Affairs Specialist…

    Medtronic (Santa Rosa, CA)
    …solutions. This role will be based in Santa Rosa, CA. The **Principal Regulatory Affairs Specialist** will support Research and Development programs with early ... maintaining a strong foundation for future software product development for the Regulatory Function and may also support broader Medtronic enterprise working… more
    Medtronic (07/25/25)
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  • Regulatory Affairs Specialist

    Envista Holdings Corporation (Brea, CA)
    regulatory correspondence and approvals (ex: FDA, HC, EU and ROW). + Provide regulatory support for Health Authority submissions including but not limited to ... partnership with manufacturing and RA/QA in designing and enhancing quality management systems to facilitate overall regulatory compliance. + Responsible for… more
    Envista Holdings Corporation (06/03/25)
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  • Staff Specialist Regulatory Affairs…

    BD (Becton, Dickinson and Company) (San Diego, CA)
    …are required. + Ensure SaMD compliance with FDA guidance on Clinical Decision Support (CDS) software and other regulatory frameworks. + Work cross functionally ... + Ability to work collaboratively in cross-functional teams. + Proficiency with regulatory databases, document control systems , and project management tools.… more
    BD (Becton, Dickinson and Company) (05/22/25)
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  • Associate Director, Regulatory Affairs…

    AbbVie (Irvine, CA)
    …for the assigned medical device or device aspect of combination products. Support regulatory intelligence and policy activities in monitoring regulatory ... Authority/Notified Body project-specific meetings as well as industry meetings. Provide regulatory support , project management and leadership for the (Medical… more
    AbbVie (08/08/25)
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  • Senior Manager Regulatory Affairs - Global…

    Abbott (Santa Clara, CA)
    …requested + Identify and present option for risk mitigation to decision makers + Support regulatory trackers for submissions to identify areas for new or ... regulatory environment. Demonstrates ability to interpret and apply regulatory requirements to software systems , including documentation, risk management,… more
    Abbott (08/08/25)
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