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The IRB Regulatory Consultant will work with investigators, study staff, local and Central Institutional Review Board, and the sponsor of the clinical trial to ensure that the studies are conducted in compliance with ICH GCP, the FDA, IRB, and other regulatory requirements.
$80,000Full-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Experience in working with FDA regulations and guidelines, 21 CFR, ICH guideline and initiatives governing regulatory operations and submissions (pharma, biotech, medical devices). Establish and maintain regulatory study files (electronic and Physical) to ensure that all essential regulatory documents are up to date, complete and in compliance with the requirement of ICH -GCP, IRB, the FDA, and other applicable regulations.
ExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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Familiarity with FDA regulatory process. The Clinical Data Scientist position interacts with many FDA stakeholders across several Offices and Centers specifically with clinical reviewers (Medical Officers) and statistical reviewers.
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Interact and negotiate with regulatory agencies / Notified Bodies to support product life cycle management, including FDA for Class II and III Pre-Submission Meetings and PMA submissions, Health Canada for Class III/IV submissions, and EU MDR Class I - IV submissions and change notifications.
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Compliance Adherence: Ensure strict site adherence to regulatory requirements, including implementing SOP's, US FDA Good Laboratory Practices (GLP), and current Good Manufacturing Practices (cGMP) under preclinical to clinical grade testing.
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As a Senior QA Associate, Compliance/QA Lead , you would be responsible for ensuring product compliance to established cGMPs, to meet safety and quality standards for FDA Regulatory and customer requirements by adherence to Standard Operating Procedures (SOPs.
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Thorough understanding of federal regulations including U.S. Food and Drug Administration (FDA), National Institute of Health (NIH), Department Health and Human Services (DHHS); International Conference on Harmonization Good Clinical Practices (ICH GCPs), and Institutional Review Board (IRB) policy.
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Understand, display knowledge and supervise execution of FSQA programs including, but not limited to BRC systems, HACCP, sanitation, pest control, good manufacturing practices, foreign material control, customer complaint, deviation investigation process, Root-cause analysis, traceability, internal audit program, trainings, food defense and security to comply with all company, Customer and USDA/FDA regulatory requirements.
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The primary responsibility will be to interpret and report clinical cases in molecular diagnostics and assist the Division Director with assay design, feasibility studies, and clinical validation consistent with all regulatory guidelines (CAP, CLIA, FDA.
Full-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Clinical chemistry, immunoassay FDA & EU or Class III medical device experience with broad knowledge of medical device industry, regulatory requirements, and frameworks. Comprehensive knowledge of FDA & EU IVD regulations experience including a conversant knowledge of evolving China regulatory expectations.
$117ExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Interact with R&D, Marketing, Regulatory, Medical and Scientific Affairs, and other global functions as well as senior leadership teams and global partners to apply advanced critical thinking to build strategic plans for new biomarker development, stakeholder management, and technology dissemination such as Real-World Evidence, ensuring benefit from the new capabilities and opportunities these enable.
$117Full-timeExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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Fulfill role as SQF Practitioner (both food safety and quality), HACCP coordinator, and PCQI in compliance with FDA Food Safety Modernization Act. · PCQI and HACCP certification and very strong HACCP and regulatory skills.
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Be responsible for required device and accessory product change submissions - FDA and EU MDR, EU Cert Renewals, e-Labeling, along with required product release approvals (PRA). Recruiter: Spencer Gregory Hale Regulatory Affairs Manager - Core CRM Sustaining Program Regulatory POC Team Purpose: The Rhythm Management (RM) Regulatory Affairs leadership team is a strategic partner that delivers innovative, efficient, and sustainable business and regulatory solutions for customers throughout the product lifecycle.
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The Research Regulatory Specialist III functions as a liaison between the IRB of record for each study protocol, the Food and Drug Administration (FDA), and the investigator, the AHRI study team, other study teams participating in AHRI led multi-site studies, the Sponsor, Contract Research Organization (CRO), Office of Sponsored Programs (OSP), the research Conflicts of Interest (COI) office, the clinical research department Managers and Sr. Managers, and AHRI Leadership.
Full-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Or, ABMGG board certified/eligible for certification in Clinical Cytogenetics and Genomics. Or Clinical Molecular Genetics and Genomics. One (1) year of proven clinical laboratory experience in diagnostic review and reporting, molecular assay design, validation, and implementation compliant with CLIA and CAP guidelines.
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fda regulatory jobs Title: principal consultant Company: Parexel
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