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  1. Regulatory Affairs Specialist

    ·         Guides or supports the creation and filing of appropriate EU/US submissions to ensure in vitro diagnostic devices are commercially available in Europe and/or U.S. Guides regulatory projects, project schedules, and product introduction process. ·         Depending on experience, guides the decision making process on regulatory submission issues using historical knowledge, legal counsel and FDA's current regulations on medical device industry. ·         Bachelor’s degree in scientific ...

  2. Clinical Regulatory Affairs Med Devices - Sunnyvale, CA

    Seeking experience with IDE's, PMA's and 510k's to ensure regulatory and ISO 13485 comliance and get regulatory approval for medical devices. Shall oversee management of manage content, assembly, pre-final review, and filing of medical device applications. Enjoy the career path opportunities that only a growing company can provide while earning a top salary plus bonuses and full company paid benefits – Medical, dental and a vision plan, prescription drug plan, flexible spending account, short and ...