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regulatory affairs in Orange County

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  1. Regulatory Affairs Specialist - Medical Devices

    Regulatory Affairs Specialist - Medical Devices Global leader in the development of life saving medical devices seeks a regulatory affairs specialist to lead regulatory submittals to the FDA and other regulatory agencies.  The Regulatory Affairs Specialist will: Write, coordinate, compile and submit regulatory documents to FDA, EPA, TUV and other international regulatory agencies. Prepare international documents including technical files Work to gain speedy approval of new products as well as ...

  2. QA / Scientific Affairs - Regulatory Affairs Sr. Specialist

    Ensures compliance to FDA and other applicable regulations. Prepares, analyzes, and submits dossiers to various governing agencies in supporting business growths. Supports applicable regulations including ISO, local, state, and/or federal requirements. • Monitor proposed regulatory changes from the FDA and other agencies including worldwide regulatory authorities and provide management with impact of changes in the Regulatory environment. • Review related regulatory publications and documents to ...

  3. Quality Manager (Medical Device)

    Our client is an exciting small company that is well-funded by top venture capital investors. This is a great opportunity to work in an exciting therapeutic area! This position is for a Quality Manager. The successful candidate will be responsible for serving as the lead technical resource of the Quality Assurance department and the management representative; work closely with R&D participating as a member on the product development team; develop risk analysis documents as required to support ...

  4. Principle Clinical Affairs Sr. Specialist

    The position oversees the clinical trial process for new diagnostic products. The process includes participating in the development of clinical trial protocols, establishing the capabilities required for the clinical trial sites to complete the protocols, identifying sites having the proper clinical trial capabilities, managing the clinical trial contract process, and managing the clinical trial sites for compliance. Training of clinical trial sites and internal departments such as Technical Services ...