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regulatory affairs in San Diego

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  1. Vice President, Regulatory Affairs

    Vice President, Regulatory Affairs Summary: The Vice President, Regulatory Affairs leads the development, implementation, and direction of effective regulatory strategies with oversight for all of quality and compliance for the company's oncology pharmaceuticals. The position has responsibility for tracking and evaluating governmental and international regulations and their impact relative to drug regulation. The incumbent builds and maintains excellent relationships with the FDA, other health ...

  2. Vice President, Regulatory Affairs

    HRC 17-21Vice President, Regulatory AffairsSummary: The Vice President, Regulatory Affairs leads the development, implementation, and direction of effective regulatory strategies with oversight for all of quality and compliance for the company’s oncology pharmaceuticals. The position has responsibility for tracking and evaluating governmental and international regulations and their impact relative to drug regulation. The incumbent builds and maintains excellent relationships with the FDA, other ...

  3. Software Quality Engineer

    Must have experience testing software that controls a device. Website software testing is not a fit! Plans, writes test cases, UITs, UIT Reports, and tests software requirements, root cause analysis, develop instructions and documentation for manuals, V&V plans, acceptance criteria documents and project plans. Assist with creation of Tools, Tools validation protocols, and executes complex test protocols. Experience supporting Regulatory Affairs for 510(k) and ensuring software validation procedures ...

  4. Director Clinical Development - Hematology-Oncology

    HRC 11-04Director Clinical Development Hematology-Oncology(Title Commensurate with Experience) Under the supervision of the Vice President of Clinical Development and Medical Affairs, the Clinical Development team member drives and executives the goals for the study design, plan, protocoldevelopment, implementation and monitoring of the company’s Phase I/II Oncology/Hematology clinical trials. The position will provide key overall clinical, scientific and/or logistical support toclinical development ...