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Regulatory Affairs SpecialistSilicon South - Orange, CAPlan, execute and maintain regulatory activities within the United States and International markets.Responsibilities:Ascertain compliance with relevant FDA, MDD, ISO both for US and global regulations.Participate on teams, providing US and/or International regulatory strategy and execution.Develop US and International regulatory strategies for product submissions, identifying needs for bench, animal and clinical testingKeep company informed of regulatory requirements in the US.Provide regulatory strategy, timelines, and directionPrepare US and International submissions. Work with FDA to obtain product approval/clearanceAs needed, ensure relevant ISO and FDA Export requirements are metReview Change Orders and assess regulatory impact of product changes on US and/or International regulatory... See job listing >30+ days ago from Jobirn - Save - Block - Flag - More Tools...
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Regulatory Affairs Specialist jobs in Orange, CA
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Regulatory Affairs SpecialistSilicon South - Orange, CAregulatory requirements in the US.Provide regulatory strategy, timelines, and ... product approvalsDevelop and maintain regulatory affairs department...14 hours ago from Jobirn - Save - Block - Flag - More Tools...
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Senior Regulatory Affairs Specialist (Medical Devices)Masimo - Irvine, CAus, please visit: www.masimo.com Senior Regulatory Affairs Specialist (Medical ... an integral part of an expanding regulatory affairs team that is responsible for...12 days ago from Talent Exchange - Save - Block - Flag - More Tools...
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Senior Quality And Regulatory Affairs SpecialistBeckman Coulter - Brea, CAQuality and Regulatory Affairs Specialist Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. Our...30+ days ago from Beckman Coulter, Inc. - Save - Block - Flag - More Tools...
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Regulatory Affairs ManagerAerotek Scientific - Santa Ana, CARegulatory Affairs Manager to support their Regulatory Affairs department. This person ... trials for Med Device products. - Develop regulatory strategies for new products. -...8 days ago from TweetMyJOBS - Save - Block - Flag - More Tools...
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Silicon South jobs
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Program ManagerSilicon South - Orange, CAThe Program Manager will be responsible for the product management and tracking engineering processes of medical devices and technologies. In addition, you will be a key player in...14 hours ago from Jobirn - Save - Block - Flag - More Tools...
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Systems Software EngineerSilicon South - Orange, CADuties:Design, Implementation and Maintenance of test and validation plans, procedures and equipmentAutomation of test execution using scripts, tools and softwareTest Plan, test...14 hours ago from Jobirn - Save - Block - Flag - More Tools...
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Product ManagerSilicon South - Orange, CAResponsible for developing and managing common activities across all OEM's, including development and maintenance of OEM training programs, processes, product lines and schedules...14 hours ago from Jobirn - Save - Block - Flag - More Tools...
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Product Manager, OEMSilicon South - Orange, CAResponsible for managing key OEM relationships including technical support, quarterly business reviews, and relationship management to support the integration of technology.14 hours ago from Jobirn - Save - Block - Flag - More Tools...
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