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regulatory affairs in Orange County

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  1. Director of Regulatory Affairs

    Description Medical device company focused on the development of- an innovative solution for the common age-related loss of the ability to read or focus on near objects. Our solution responds to the market's need for a surgical procedure that is safe, effective, quick, and easy to learn and practice. Position Summary: The Regulatory Affairs Director will ensure compliance with existing, new and/or revised regulatory requirements applicable to the company. The candidate must have a solid foundation ...

  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 ...