• Program Manager, Regulatory Affairs,…

    GE HealthCare (Chicago, IL)
    …product launch, premarket submissions/registrations and post-market compliance, working closely with healthcare regulatory bodies globally. Has knowledge of best ... product launch, premarket submissions/registrations and post-market compliance, working closely with healthcare regulatory bodies globally. + Prepares global … more
    GE HealthCare (06/25/25)
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  • Associate General Counsel, Senior Director…

    Oura (San Francisco, CA)
    …legal experience, including both private practice and in-house, in corporate healthcare regulatory compliance, privacy compliance, and ethics programs, ... privacy and regulatory compliance with commercial objectives. What you will do: FDA & Global Regulatory Compliance: + Serve as the primary legal advisor… more
    Oura (08/17/25)
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  • Director, Quality & Regulatory Business…

    GE HealthCare (Waukesha, WI)
    …to GE HealthCare policy objectives. + Regularly advises Quality and Regulatory management in business development. Has a supportive role in decision making about ... informed of industry trends that may influence work. GE Healthcare is a leading global medical technology and digital...issues (directly). + Experience with Pharma QMS requirements and regulatory requirements including but not limited to FDA more
    GE HealthCare (08/26/25)
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  • Regulatory Compliance Specialist

    Houston Methodist (Houston, TX)
    …and the International Conference on Harmonization (ICH). This position communicates with regulatory affairs office for FDA submissions across multiple studies of ... **SERVICE ESSENTIAL FUNCTIONS** + Ensures compliance of general and study-specific regulatory and/or safety-related processes with SOP's, FDA , GCP, NIH… more
    Houston Methodist (07/29/25)
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  • Senior Manager Regulatory Affairs - Global…

    Abbott (Santa Clara, CA)
    …legislation, regulations, and guidances + Communicates with internal groups to share updates on regulatory changes as it pertains to the FDA + Utilizes technical ... Abbott is a global healthcare leader that helps people live more fully...and maintenance in regulated environments. + In-depth knowledge of regulatory frameworks (eg, FDA , EMA, ISO 13485,… more
    Abbott (08/08/25)
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  • Associate Director, Regulatory Affairs

    Glenmark Pharmaceuticals Inc., USA (Elmwood Park, NJ)
    Associate Director, Regulatory Affairs Department: Regulatory Affairs Location: Elmwood Park, NJ START YOUR APPLICATION ... communication to support both internal and external customers (globally) including the US FDA . Job Responsibilities Note: These statements are not intended to be an… more
    Glenmark Pharmaceuticals Inc., USA (08/15/25)
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  • Staff Specialist Regulatory Affairs…

    BD (Becton, Dickinson and Company) (San Diego, CA)
    …execute comprehensive regulatory strategies for SaMD products in alignment with FDA regulations and guidance documents. + Provide regulatory input during the ... Guidance and SaMD related Guidance. + Knowledge of international regulatory requirements (eg, FDA QSR, ISO 13485,...and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum… more
    BD (Becton, Dickinson and Company) (08/21/25)
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  • Head of COA Regulatory Strategy, Patient…

    IQVIA (Durham, NC)
    …true expert in both the guidance and the practice of developing strategies to engage US FDA , the EMA and other regulatory agencies on COA endpoints and the use ... and consortia + Lead development of IQVIA's responses to public consultation processes from FDA and other regulatory agencies relating to PED + Contribute to the… more
    IQVIA (07/01/25)
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  • Staff Regulatory Affairs Specialist

    BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
    …**Preferred Qualifications:** + Demonstrated success in the preparation and completion of regulatory submissions (Qsub, PMA, 510(k), IDE) to FDA and other ... global regulatory agencies and experience negotiating with regulatory authority personnel (eg FDA , Notified Bodies) preferred + Must demonstrate ability to… more
    BD (Becton, Dickinson and Company) (07/18/25)
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  • Sr. Director - Global Regulatory Affairs…

    Lilly (Indianapolis, IN)
    …across GRA** + Partnering with Therapeutic Directors from GRA to consider FDA Review Division perspectives and relevant regulatory history in advertising ... in US Regulatory Advertising and Promotion + Comprehensive knowledge of FDA procedures and practices across Review Divisions and OPDP (CFR guidelines, Guidances,… more
    Lilly (08/08/25)
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