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The newly established Immune Health Initiative is hiring a full-time Regulatory Affairs Specialist or Senior Regulatory Affairs Specialist to assist with departmental IRB maintenance and submissions and to perform routine internal study monitoring for all observational clinical research studies.
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The Clinical Trials Regulatory Specialist I is an entry-level position supporting regulatory affairs in clinical trial research. Assists regulatory team (Regulatory Specialist II and III) in research efforts by facilitating the protocol approval process and maintaining documentation of regulatory compliance throughout the trial's duration for research studies involving human subjects.
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Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. We are presently hiring for a Regulatory Affairs Specialist, as part of the Regulatory Affairs Asia Pacific (APAC) team, on-site at our Diabetes Care Division HQ location in Alameda, CA. As an individual contributor, the function of a Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment.
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Preferred Experience: Specialized training/certification in Regulatory Affairs or Clinical Research. The Research Regulatory Specialist performs a wide range of tasks essential to the submission, approval, and maintenance of required regulatory documents for conducting clinical research in compliance with the Federal Food and Drug Administration (FDA.
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Bachelor's degree PLUS Three (3) years of experience in clinical research related to FDA Regulatory Affairs. Regulatory Affairs Specialists will be directly involved in ensuring regulatory compliance and administrative management for multiple clinical trials, working closely with investigators, industry sponsors, contract research organization representatives, and UAMS institutional oversight offices.
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Analyzes advanced scientific and biomedical research web-based, peer-reviewed and vendor-sourced technical materials pertaining to ingredients, technologies, clinical studies, physiology, chemistry and safety in order to create recommendations, develop product concepts, write and substantiate structure/function (S/F) and cosmetics claims, as well as other marketing materials.
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2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. This Senior Regulatory Affairs Specialist position is an on-site opportunity working out of our Santa Clara, CA location in the Abbott Vascular Division.
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This role requires working under tight timelines supporting the Regulatory Affairs team while maintaining communication with QA, Product, Operations, and other functions as required. We are growing our footprint with leading health systems, clinical research organizations, academic medical centers, and more who are looking to deliver clinical-grade, convenient diagnostic tests to their patients.
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This is a unique opportunity for a talented Regulatory Affairs Specialist to contribute to the preparation, organization, and tracking of regulatory submissions across specific countries in the EMEA region.
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As the Staff Regulatory Affairs Specialist, you will work to maintain medical devices on the market and ensure ongoing compliance. Staff Regulatory Affairs Specialist.
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Level II: Three (3) years general research experience with demonstrated experience/proficiency in one or more of the following functional areas as relevant to oncology clinical trials: study planning/development, regulatory and/or financial start-up, regulatory maintenance and reporting from study activation to closeout AND Obtain CRS certification within Two (2) years of hire.
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Upon request from investigators, conduct pre-reviews of draft documents (such as new protocol submissions, exemptions, and changes of protocol) and advise investigators and research coordinators regarding potential ethical, regulatory, editorial or content issues before they are submitted for full IRB review.
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As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products.
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Job Segment: Regulatory Affairs, Compliance, Medical Device, Electrophysiology, Clinical Research, Legal, Healthcare. Minimum of 8 years of regulatory affairs or related experience, or 5 years' experience with an advanced degree (Masters or PhD.
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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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regulatory affairs clinical research jobs Title: regulatory specialist
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