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Knowledge of USDA and FDA labeling regulations, Canada, EU a plus. Proof packaging artwork for accurate information at each stage in the design process including graphics review, printing, production.
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Relationship Management: Cultivate strong relationships with regulatory authorities, including the FDA, EMA, and other global health authorities, serving as the primary liaison for regulatory interactions and communications.
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Demonstrated knowledge of JCAHO, DPH, FDA requirements and standards related to med/surg supplies and equipment handling and storage. Must communicate JCAHO, DPH, FDA requirements and standards to staff and monitor compliance.
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Extensive knowledge of FDA regulations and practices and ICH guidance as well as strong knowledge of global health authority regulations and practices. Led FDA interactions. Minimum of 6 years of regulatory affairs experience in the biopharmaceutical industry, with a focus on rare diseases/oncology and orphan drug development.
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DLA Piper is seeking an information governance and data strategy mid-level attorney with 4-6 years of relevant experience to join its FDA Regulatory group in our Washington, D.C. or Boston offices.
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Understanding and working knowledge of principles of SOPs, GCP, FDA, IRB, clinical research methodology, regulations, and compliance required. The CICL provides echocardiography core laboratory services for primarily large-scale global clinical trials responsible for site training and interface as well as echo analysis of images received.
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Plan, prepare and participate in all audits including: organic, kosher, customer, FDA, internal and 3rd party. Exposure to FDA approved cleaning chemicals. The QC Manager will be responsible for writing new HACCP plans, SOP's for production and assisting with tasks related to auditing as directed by leadership.
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In depth knowledge of HACCP, FDA, and SQF/GFSI requirements. Bachelor's Degree in Biology, Microbiology, Food Science, Animal Science, Quality Assurance or a related field. The QC Manager will be responsible for ensuring Food Safety Compliance and Quality Assurance for the Company and its products.
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The Associate Director/Director Biostatistics is responsible for providing technical leadership and biostatistical support to Clinical Development through the design and conduct of clinical studies; review and accuracy of clinical data; the evaluation, interpretation, and reporting of study results; and regulatory submissions to the FDA and other regulatory agencies.
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Expert knowledge of global GCP requirements and applicable drug development regulations, including USA (FDA), EU (EMA, MHRA), and ICH Guidelines. Prior experience as a CRA, Study Coordinator, or in clinical study management is strongly preferred.
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As the PRC Regulatory Affairs representative, you will work with brand on competitively positioning assigned products appropriately while maintaining compliance with applicable FDA regulations, company policies, and applicable Industry Guidelines for the advertising and promotion of prescription drugs, biologics, and devices.
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You've acquired 5+ years' experience in UI/UX design, with a detailed understanding of healthcare systems, clinical workflows and software solutions in FDA regulated, medical product/software environments.
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Experience working in an FDA regulated manufacturing environmentAbout MedtronicTogether, we can change healthcare worldwide. We are looking for a Sr. Supplier Quality Engineer who will be a part of our Global Supplier Quality team.
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Current knowledge of FDA regulatory guidance related to nonclinical and clinical pharmacology; experience having direct interaction with FDA, including submission of IND, NDA and other regulatory documents.
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Strong demonstration of knowledge of drug development, FDA, EMA and ICH guidelines and regulationsExcellent organizational and communication skills, both written and verbalAbility to work independently as well as part of a team environment.
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