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The three (3) years of experience as Regulatory Specialist and/or Compliance Analyst must have included the preparation and submission of regulatory compliance documents for a financial services institution with a focus on LATAM regulatory strategy, compliance, audit, and risk control framework.
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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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They will help to create drafts, updates, maintains, interprets and provides guidance on PSC regulations and policies, in consultation with M/OAA/P, HCTM, GC and relevant B/IOs, and shepherd regulatory and policy proposals through the Agency, the Office of Management and Budget, Office of Information and Regulatory Affairs (OMB/OIRA) and the Federal Register approval process.
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Prometheus Federal Services (PFS), a trusted partner to federal healthcare agencies, is currently seeking a Credentialing Support Specialist to be a part of a team supporting federal contracts with the U.S. Department of Veterans Affairs (VA) / Veterans Health Administration (VHA.
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This role will interface with other Insulet departments (e.g. Research and Development, Lifecycle Engineering, Operations, Engineering, Human Factors, and Regulatory Affairs) as well as other external parties on issues related to product development, launched product support, and services to support our medical devices, partner integrations, and data analytics.
$109,060 - $155,065 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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CLEARANCES & HEALTH REQUIREMENTSThe following background checks are conducted by Hilltop Community Resources:Hilltop Criminal Background CheckCBI Records CheckSex Offender RegistryDriving RecordColorado Adult Protective Services Background Check (CAPS)Colorado Department of Regulatory Affairs (DORA) CheckDepartment of Health and Human Services Office of Inspector General (OIG) Exclusion ListTuberculosis (Tb) Skin TestN95 Mask Fit TestInfluenza VaccinationAny other required vaccination.
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Maintain Regulatory Affairs product files to support compliance with regulatory requirements. Certification such as RAC (Regulatory Affairs Certification) is often preferred.
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Position Overview Reporting to the Senior Manager of Medicare Regulatory Compliance, the Medicare Regulatory Compliance Specialist will support the oversight and management of the Medicare Compliance Program.
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Special emphasis on consultation, support, compliance, and capacity development regarding Tribal agribusiness enterprises, Tribal food and agricultural systems, and direct/indirect services related to food, agriculture and natural resources will be a key component of job responsibilities.
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Experience building regulatory strategies to support successful regulatory affairs team. 5+ years of regulatory affairs experience preferably in the medical device industry, with proven experience in electro-mechanical products required.
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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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We support a wide range of functions, including Biometrics, Clinical Development and Operations, CMC, Medical Affairs, Medical Writing, Program Leadership, Quality Assurance, and Regulatory Affairs, among others, provided by a team of industry veterans.
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Working closely with internal cross-functional impacted areas, such as External Plant Operations, CMO Management, CMC/Regulatory Affairs and Technical Services to resolve open issues in a timely manner resulting from record reviews and deviation events.
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The Specialist will liaise with cross-functional departments to ensure regulatory requirements and internal standards are met and support the success of drug development programs within GRDRA Americas.
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We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.
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