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This Senior Regulatory Affairs Specialist will have an opportunity to work on new to market technology that is improving the field of diagnostic imaging and saving patient lives. Senior Regulatory Affairs Specialist-Remote Based-West Coast.
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You will provide global product stewardship and regulatory affairs services for a line of chemical products that support Videojet printers. Manage our SDS, label, and regulatory affairs systems.
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This role requires the functional understanding of Regulatory Affairs processes and the ability to perform database analysis, uploads and verification into the system to support the Global Regulatory Affairs function, as well as Integra LifeSciences.
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Manage accurate and timely safety related regulatory reporting (AEs, SAEs, UADEs) per study and regulatory requirements including collaboration with regulatory affairs and clinical operations, or overseeing activities of third-party managing safety reporting.
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The Regulatory Affairs Specialist will be responsible for ensuring compliance with all regulatory requirements related to the development, manufacturing, and distribution of our products.
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The Senior Regulatory Affairs Specialist provides regulatory guidance to cross-functional teams; develops global regulatory strategies; advises on labeling and marketing materials for regulatory compliance; and evaluates product changes for impact on regulatory filings worldwide.
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Specialist Regulatory Affairs (Poultry) Specialist Regulatory Affairs page is loaded. Specialist Regulatory Affairs. Global Regulatory Affairs (GRA) is accountable for licensing and maintaining pharmaceutical and biological animal health products globally.
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POSITION OVERVIEW: The Regulatory Affairs, Accreditation & Safety Specialist (RASS) provides regulatory and safety expertise as related to Joint Commission, CMS, Oregon Health Authority, Pharmacy Board, OSHA, and other regulatory agencies.
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Working with R&D, regulatory and scientific affairs, brand teams, consumer insights, nutrition research, and legal, you will identify and promote nutrition and well-being opportunities and claim development across various media (packaging, advertising, websites, materials for nutrition/health professionals, etc.
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TA specialist collaborates with affiliate MI and relevant internal partners who may include medical affairs, development, regulatory, global patient safety and operations, and commercial, to manage global response topics and content.
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The Senior Clinical Regulatory Specialist will work under the direction of the Director of Regulatory Affairs with the primary responsibility of assisting with the conduct and compliance of Phase 2-4 pharma sponsored research studies.
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The Senior Regulatory Affairs Specialist originates appropriate documents to obtain and maintain marketing privileges consistent with applicable government and local regulatory requirements where AtriCure conducts business.
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As the Regulatory Affairs Operations Specialist, Ad/Promo, you will play a pivotal role in ensuring regulatory compliance and operational efficiency within our organization.
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Support Hoxworth Blood Center's safety, cGMP, and Quality Plan in coordination with the Division Director, Quality and Regulatory Affairs. HBC is recruiting for Manager, Biomedical Engineering, to manage the daily operations of the Biomedical Specialist team, and ensure strict compliance with product quality assurance, equipment and procedural standards, health and safety protocols.
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You will handle policy compliance by assisting in the formulation of processes and procedures for negotiation of contract awards, review contract and sub-agreements for government/regulatory compliance with policies and statutes, review new legislation, and coordinate with SDSU Offices of Research Affairs, Business and Financial Affairs and Environmental Health and Safety.
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