• Manager Out-of-Specification (OOS) & Expanded…

    Gilead Sciences, Inc. (Santa Monica, CA)
    …visualization tools (eg, Power BI, Tableau). + Thorough knowledge of Food and Drug Administration ( FDA ), European Medicines Agency (EMA), and other applicable ... clinical operations expertise, cross-functional leadership, and deep understanding of regulatory , safety, and Medical Affairs frameworks. **Key Responsibilities** **OOS… more
    Gilead Sciences, Inc. (01/07/26)
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  • Clinical Research Manager (6-Month Fixed-Term)…

    Stanford University (Stanford, CA)
    …Complete annual reports to Institutional Review Board, CSTA, FDA and other regulatory agencies. Submit Investigational New Drug applications to the FDA ... and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. + Knowledge… more
    Stanford University (12/17/25)
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  • Director, Strategic Clinical Development

    United Therapeutics (Research Triangle Park, NC)
    …all assigned programs from inception (Phase 1-3) to successful product approval by the FDA and other regulatory agencies. + Design and review clinical protocols, ... regulatory guidelines + Knowledge of clinical science as applicable to drug development + Medical, scientific, and/or regulatory writing experience +… more
    United Therapeutics (12/26/25)
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  • Clinical Research Coordinator 2 - Surgical…

    Stanford University (Stanford, CA)
    …Complete annual reports to Institutional Review Board, CSTA, FDA and other regulatory agencies. Submit Investigational New Drug applications to the FDA ... and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. + Knowledge… more
    Stanford University (01/06/26)
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  • Design Control Engineer/Specialist

    GE HealthCare (Cleveland, OH)
    …(SaMD) Demonstrated understanding of Medical Device Quality Management System requirements and regulatory requirements, including but not limited to FDA CFR 21 ... an effective design, development, and transfer process that adheres to applicable FDA , EU regulations, ISO 13485:2016, and other governing regulations applicable to… more
    GE HealthCare (01/03/26)
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  • Quality Assurance Manager - K12 Food Service

    Compass Group, North America (Jacksonville, FL)
    …food safety and quality assurance programs to ensure compliance with USDA, FDA , FSIS, FSMA, customer, and corporate requirements. This role provides leadership in ... protecting product integrity, ensuring regulatory compliance, and fostering a strong food safety culture...supply-chain controls, allergen controls, and prerequisite programs meet USDA, FDA , FSIS, FSMA, and corporate standards. + Serve as… more
    Compass Group, North America (12/24/25)
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  • Senior Manager US Advertising & Promotion Lead

    CSL Behring (King Of Prussia, PA)
    …the most important aspects and duties. + Ensure compliance with HA drug promotion and promotional labeling regulations for assigned licensed products. + Review, ... or reject promotional programming based on US Code of Federal Regulations and FDA implementing regulations and guidance. + Adhere to related SOPs and work… more
    CSL Behring (12/17/25)
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  • Staff Software Design Quality Assurance Engineer…

    Caris Life Sciences (Irving, TX)
    …are in accordance with internal SOPs, Quality System Requirements which include ISO 13485, FDA QSR, IVDR, SOX, SOC2, and IEC 62304 + Reviews and approves various ... and applicable Software Validation Planning documents in alignment with FDA QSR, 21 CFR Part 11, and GAMP5 regulation...Part 11, and GAMP5 regulation requirements. + Collaborates with regulatory partners as a software quality subject matter expert… more
    Caris Life Sciences (12/10/25)
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  • Manager Environmental Health & Safety (EHS)

    Abbott (Altavista, VA)
    …applicable business policies, laws and regulations, inclusive of US Food and Drug Administration ( FDA ) regulations, Occupational Safety & Health Administration ... Manufacturing Practices (GMP's), Environmental Protection Agency (EPA) and other regulatory requirements, company policies, operating procedures, and processes. Interface… more
    Abbott (11/18/25)
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  • Associate Director, Medical Writing

    Taiho Oncology (Princeton, NJ)
    …procedures. Performance Objectives: + Responsible for authoring TOI documents submitted to Regulatory Authorities (eg FDA and EMA) including Clinical Study ... for authoring Taiho Oncology, Inc., (TOI), documents submitted to Regulatory Authorities including Clinical Study Reports, Investigator Brochures, Protocols,… more
    Taiho Oncology (01/07/26)
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