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Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB). Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
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Ensures compliance with applicable Inova standard operating procedures (SOPs), ISO, FDA and other Quality System regulations, as well as applicable Environmental Health & Safety, Human Resources and all other regulatory and administrative policies.
$20 - $27 an hourFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Reviews sample run data and quality control data and ensures all regulatory compliance standards are met while following established SOPs. Ensures proper entry of specimen data and testing results into databases or the laboratory information management system (LIMS), providing oversight of junior staff activities.
$57,650 - $71,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Strong understanding of FDA and international regulatory requirements for early development of cell therapy products. - Stay current on regulatory trends and developments in early development of cell therapy products to ensure compliance and strategic advantage.
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In-depth knowledge of global regulatory requirements, including FDA and ICH cGMP/GLP guidelines. Oversee and lead the Quality Assurance department, providing strategic direction and guidance to ensure compliance with regulatory requirements and industry standards.
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In partnership with management, ensure compliance with all applicable regulatory agencies, including FDA, CA FDB, OSHA, DOH, EPA, Fire Department, city audits, Health Department, etc.
$125,000 - $150,000 a yearFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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This role is expected to act as a thought partner, working with other leadership members to assure that operations in all departments run smoothly and maintain compliance with relevant regulations, including those originating from the FDA, the USDA, the NIH, or other regulatory bodies.
Starting at $175,000 - $250,000 a yearExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Demonstrated experience working with clinical trials research activities, regulatory compliance, guidelines related to IRB informed consent, as well as interpreting and comprehending complex clinical research protocols, activities and guidelines.
$62,250 - $110,000 a yearRemoteExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Develop, implement, and coordinate the quality programs in compliance with federal and global regulatory requirements to support clinical manufacturing at CMO sites. The ideal professional will have a strong background in clinical scale GMP manufacturing and knowledge of FDA and ICH regulatory requirements.
ExpandApply NowActive JobUpdated 14 days ago - UpvoteDownvoteShare Job
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Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies. Works with Manufacturing, Marketing, Purchasing and Regulatory to provide an initial analysis of implementation timing, potential scrap costs and quantities of new labeling to be ordered.
$30 - $35 an hourFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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The Specialist, Clinical Customer Advocacy is responsible for the completion of all tasks associated with complaint management and processing of event reporting, including communication for regulatory compliance with medical device reporting for both domestic and international agency regulations.
ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Strong knowledge of compliance, quality and safety as relates to all regulatory agencies, including FDA, OSHA and NRC. Maintains compliance with all regulatory requirements to include, but not limited to: FDA, OSHA, and NRC.
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As we transition into the drug product market, compliance with multiple regulatory guidelines (such as USP, FDA, ICH, JP, EU, etc.) Ensure compliance with relevant regulatory frameworks for drug product facilities (USP, FDA, ICH, JP, EU, etc.
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This includes execution of defined analytical and clinical studies to support design changes and if needed, registration and submission to regulatory bodies. This includes execution of defined analytical and clinical studies to support registration and submission to regulatory bodies.
ExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Must have excellent working knowledge of IVD design control, risk management, GCP, and regulatory affairs including US FDA and IVDR regulations. Ensures all clinical studies operate to the highest ethical and safety standards in compliance with GCP and global regulatory requirements.
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fda regulatory compliance jobs in San Diego, CA
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