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BODYMD’S EMSCULPT NEO is the world’s only FDA cleared body sculpting procedure that burns fat and builds muscle! The ideal candidate will have a strong background in medical spa sales, pharmaceutical sales or aesthetic sales.
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Ensures assigned studies are conducted in accordance with the Food and Drug Administration (FDA), Office for Human Research Protections (OHRP), Good Clinical Practices (GCP), Institutional Review Board (IRB), HIPAA regulations and institutional requirements, which includes, but not limited to, the following duties: Knowledge of all regulatory requirements and institutional requirements when conducting the study protocol(s.
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Handle all complaints according to FDA/ISO/cMDR and other regulations governing medical devices and HIPAA regulations. Create requests in appropriate databases to support customer orders such as new customer account set up, customer pricing, required quality or export documentation or certificates.
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Prepare or coordinate the preparation of Q-submissions, 510(k) and/or PMA submissions to FDA. Seek input from outside consultants and regulatory attorneys to define and confirm potential pathways with FDA.
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Experience participating and providing support during third party audits such as BSI, FDA, others. Familiarity with ISO and FDA requirements on Design Controls and CAPA Methodologies. A minimum of 3 years of experience working within FDA regulated environment, preferably in the IVD or medical device manufacturing space.
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Optimize resources while ensuring raw materials and finished product meet specifications and manufacturing standards and in accordance with FDA, CFIA, GMP's, HACCP, and all other governmental policies, procedures, and regulations.
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Strong knowledge of the drug development process, including Good Clinical Practices (GCPs) and FDA Code of Federal Regulations. Proficiency with CTMS, RAVE, Veeva Vault systems highly recommended.
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Maintaining a working knowledge of current FDA regulations, GCP/ICH guidelines, organizational SOPs, guidance documents, and study protocols. Performing clinical safety assessments and monitoring for study trial participation to include such items as: physical exams, EKGs, phlebotomy, and lab work evaluation.
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The candidate requires knowledge of FDA, USDA, GFSI, NAFTA and other industry guidelines for Safe, Quality Food Production and documentation methods to meet requirements. Qualifications desired: Experience with Statistical Process Control analysis in food manufacturing environment Familiarity with BRC, FSMA, NAFTA and HACCP Progressive increase in quality assurance responsibility in batter and laminated products in a manufacturing environment.
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Ensure all plant employees are responsible and accountable to maintain GMP and site standards which include FDA, and USDA standards. At APS BioGroup, a division of Glanbia Nutritional’s Inc, our portfolio centers on dairy nutritional ingredients.
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Support engagements with regulatory authorities (e.g., FDA, EMA) on behalf of customers, across the lifecycle of drug development from pre-clinical to licensing, including contribution to briefing documents and other meeting materials, and attendance and contribution to meetings and other interactions.
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Maintain records and follow laboratory procedures to meet regulatory requirements such as FDA, CLIA, and/or CAP. The Senior Engineer responsibilities are validation, configuration management, and partner with various groups for process improvement and system development for the Next Generation Sequencing clinical laboratories in Phoenix.
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Ensure that ingredients and nutritional statements on production art files, printed material and web-based data are % accurate and comply with FDA and USDA labeling regulations. Must be able to read and interpret USDA and FDA regulations concerning labeling and nutrition Excellent/proven analytical and reasoning skills Must be able to conduct statistical analyses of data and identify trends Benefits In addition to a rewarding career, Sprouts offers a comprehensive program to help support you and your family.
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Experience working with SOPs, GDP, GMP, CLIA, and the FDA. As a Manager Trainee - Quality with BioLife Plasma Services, a subsidiary of global leader Takeda Pharmaceutical Company, you will learn and work in a structured management training program.
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Performs all aspects of the plasmapheresis procedure and plasma collection, including donor set-up, venipuncture, collects donor samples monitoring and disconnect in compliance with SOPs and FDA guidelines.
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fda job in Phoenix, AZ
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