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It can be valuable for candidates involved in the development and submission of IVD products to regulatory agencies like the FDA. Regulatory Affairs Certification (RAC): A certification in regulatory affairs, such as the RAC from the Regulatory Affairs Professionals Society (RAPS), can be beneficial for candidates involved in FDA IVD application processes.
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The Analyst II, Regulatory Affairs has experience with and performs key centralized complex and difficult regulatory activities for the Compliance Department. are in compliance with regulatory agencies, including but not limited to, Covered California, the Centers for Medicare and Medicaid Services (CMS), the California Department of Health Care Services (DHCS), and the California Department of Managed Health Care (DMHC), in addition to collaboration with, inter-departments to ensure member needs are met while simultaneously building strong peer relationships.
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May develop Standard Operating Procedures (SOPs) and Work Instructions (WIs) as directed by the Senior Director CMC Regulatory Affairs. Prior pharmaceutical industry experience and a minimum of 8 years in CMC Regulatory Affairs for Associate Director.
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Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Senior Regulatory Affairs Specialist. The Senior Regulatory Affairs Specialist will be responsible for developing strategies to obtain FDA clearance or approval of new Class II & III cardiovascular medical devices and improvements to existing devices.
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A scientific degree with directly relevant professional experience in small molecule development, global CMC regulatory affairs and CMC technical areas of at least 16 years with a BA/BS or 14 years with an MA/MS, PhD, PharmD, or MD.
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The University of Cincinnati, Hoxworth Blood Center is recruiting for a full-time (100 % FTE), Director, Quality Assurance / Regulatory Affairs, to oversee and direct the coordination of quality assurance and regulatory compliance for the Cellular Therapy, Therapeutic Apheresis, and Transplantation Immunology divisions.
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Executive Office support: serves as Chief of Staff to the VP, Head of Alexion Regulatory Affairs, supporting internal and external engagement and managing activities as part of the function’s Executive Office.
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Within Global Regulatory Affairs, our Chemistry, Manufacturing and Controls (CMC) organization provides regulatory leadership to CMC development teams and the Pharma Supply Chain organization to enable approval of new medicines and uninterrupted supply of our medicines to patients.
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If so, this Director of Regulatory Affairs, CMC could be an exciting opportunity to explore. Ensures all appropriate CMC regulatory aspects across teams to support change control requests including transfer of supply within GSK or with a 3rd party are delivered to agreed timelines.
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The Regulatory Affairs Specialist is expected to facilitate the development and submission of FDA IND applications and annual reports, and development/maintenance of study specific case report forms and source document tools, as well as, to provide direct regulatory/compliance guidance and facilitate investigator initiated trials and investigator-initiated multi-site trials.
$51,824 - $63,600 a yearFull-timeRemoteExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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This position is PHMSA's Supervisory Attorney-Advisor for Regulatory Affairs Law/Office of Chief Counsel, with comprehensive responsibility for the direct supervision of staff as the Deputy Assistant Chief Counsel for Regulatory Affairs.
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The Regulatory Affairs Manager is responsible and accountable for Company Core Data Sheets (CCDS), Company Core Safety Information (CCSI) and Reference Safety Information (RSI for assigned products, including regulatory responsibilities in associated change control and labeling processes.
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Senior Regulatory Affairs Specialist. Be passionate about Regulatory Affairs impact in support of the research, development, clinical, marketing, and production of state-of-the-art class III cardiovascular medical devices.
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Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society) Regulatory affairs experience in the medical device industry with a track record of successful submissions.
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Become a Regulatory Affairs Infrastructure Licensing Advisor at Southern California Edison (SCE) and build a better tomorrow. As a Regulatory Affairs Infrastructure Licensing Advisor, your work will help bring to fruition the transmission and other major projects that will help power our planet, reduce carbon emissions and create cleaner air for everyone.
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regulatory affairs jobs Title: compliance Company: U S Bank
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