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regulatory affairs in Orange County

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  1. Clinical Project Manager

    Clinical Project Manager The Clinical Project Manager manages projects and people in conducting clinical trials of medical devices to ensure: the safety of subjects, the quality and integrity of data, and the proper management of study procedures according to ICH and GCP regulatory guidelines and company Standard Operating Procedures. This position will focus on new therapies. This person will work closely with colleagues in Regulatory Affairs, Medical Affairs, Legal, Marketing and R&D to develop ...

  2. QA / Scientific Affairs - Regulatory Affairs Specialist II (3446968)

    Summary Provide pre-market regulatory strategy and implementation to ensure regulatory approval objectives that support commercial initiatives for new and modified products. Supports applicable regulations including Local, State, Federal and/or International requirements. ESSENTIAL DUTIES & RESPONSIBILITIES Represent Regulatory on core teams providing regulatory feedback and guidance throughout the product development cycle and coordinating team inputs for submissions. Prepare global regulatory ...

  3. Regulatory Affairs Specialist

    Our client is currently seeking a Regulatory Affairs Specialist in the Cypress, CA area.Summary Provide pre-market regulatory strategy and implementation to ensure regulatory approval objectives that support commercial initiatives for new and modified products. Supports applicable regulations including Local, State, Federal and/or International requirements. ESSENTIAL DUTIES & RESPONSIBILITIESRepresent Regulatory on core teams providing regulatory feedback and guidance throughout the product ...

  4. 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 ...

  5. 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 ...