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Responsible for creating standard operation procedures, protocols and compliance related documents for IT department in accordance with FDA regulatory and compliance requirements.
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The Senior Regulatory Affairs Specialist will be responsible for projects by leading biologics CMC regulatory submissions, reviews and approves advertising/promotional materials, provides regulatory input into change controls and CAPAs and support audits/inspections to ensure full compliance for US S+N site.
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Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board. Ensures compliance with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.
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Ensure full compliance with all relevant USDA/FDA and regulatory guidelines established for food manufacturing. Coordinate plant inspection activities with government and regulatory agencies to ensure compliance.
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Direct the coordination of regulatory compliance with the Food & Drug Administration (FDA), to include review of changes to regulations and FDA guidance documents; submission of biological product deviation reports to the FDA; and response to observations or findings from an FDA inspection.
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Interface with all regulatory agencies' PDA, FDA, as well as organic, koshering agencies, halal, and customers. The Quality Assurance and Regulatory Compliance Manager will be responsible for the establishment, maintenance, planning, directing and coordinating of programs, procedures and processes necessary for manufacturing food ingredients in accordance with local, state and national regulatory agencies.
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In this position you will be responsible for assuring quality and regulatory compliance including complaint handling for Oticon Medical LLC, as a US agent and initial importer of Class II Medical Devices.
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The Clinical Research Quality & Regulatory Specialist plays an integral role in the data integrity and regulatory compliance of pharmacy services related clinical research. Works closely with the Senior Research Training and Compliance Coordinator-Pharmacy to analyze internal audits, refines processes to ensure the quality of data integrity, and maintains regulatory compliance.
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Independently manage regulatory submissions to the Institutional Review Board (IRB), Institutional Biosafety Committee (IBC), Office of Clinical Research and Innovative Care Compliance (OCRICC) and the Data Safety Monitoring Committee (DSMC.
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Ensure all regulatory/compliance mandates are met before authorizing shipment which includes Lab Tests, Medical Device Listings, UL Listings, MSDS, FDA Facility Registration Number, Stuffed/Plush Toy Registration for PA, MA, and OH, Textile Registration/Declaration, Drop Ball Certificate, Fumigation Certificate, Vet Certificate, Visa/Quota, GSP Declaration, Ceramicware Certification, and CPSIA Tracking Markings.
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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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Manage quality control and regulatory requirements to ensure FDA compliance and CGMP (current good manufacturing practices) - Understanding the systems landscape and business operations end-to-end to best lead the ERP, IT systems, and FDA regulatory requirements.
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The Director of Quality Audits & Compliance is responsible to independently lead, manage, and coordinate Quality GCP and GLP regulated activities and is responsible for performance of domestic and international audits/inspections that ultimately ensure compliance to the appropriate level of Quality and regulatory standards (such as FDA, EMA, or MHRA.
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Provide current and consistent legal advice related to laws, regulations and industry trends affecting Vir and the biopharmaceutical sector, including, for example, healthcare laws, trade compliance guidance documents and regulations, healthcare regulatory issues, healthcare fraud and abuse, pharmacovigilance, advertising and labeling, product liability, pricing and reimbursement, antitrust, privacy, and other matters relevant to investigational and commercial therapeutic products.
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Relevant experience with government regulatory requirements, including cGMP, in food and beverage manufacturing (USDA, FDA, etc.) Guarantees the Company's compliance with OOS Results, Deviations, and Corrective and preventive Actions (CAPA) according to FDA standards and guidance.
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