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regulatory affairs in Orange County

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  1. 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 ...

  2. Compliance Director

    Job Description:Reporting to the Vice President of Quality and Regulatory Affairs, the Compliance Director will manage the quality management system and regulatory requirements to comply with all applicable regulations, including but not limited to FDA, ISO, as well as Federal, State, and local agencies. Supports corporate goals and business growth. Responsibilities: Ensures that the quality management system demonstrates regulatory compliance per GLP/GCP/cGMP/GXP, ISO, and other applicable ...