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You've acquired a minimum of 7 years' Regulatory Affairs experience within FDA regulated, complex Medical Device/Software (SiMD/SaMD) environments, including leadership/guidance on global regulatory strategy for 510K's, CE Marking per MDD, EU MDR (updating Technical Files), Worldwide product registrations, Design Dossiers, PMA, clinical evaluations, Post Market Surveillance and reviewing Marketing Communication materials for promotional purposes.
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Regularly interfaces with team members in R&D including Biostatistics and SAS Programming staff, Data Management, clinical research and operations teams, regulatory affairs, clinical pharmacology, medical writing, medical affairs and quality management.
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QualificationsTo be considered for this role, you’ll require a minimum of 5 years of professional experience in relevant field of healthcare products or related activities e.g.:Work in medical devices industry and/or in vitro diagnostic devices(preferred) or closely related industries (e.g., pharmaceutical industry) such as research and development, manufacturing, quality management, regulatory affairs.
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This position will work closely with the Vice President of Biostatistics and Executive Director of Data Management and Statistical Programming and other members of the clinical, pharmacovigilance and regulatory affairs teams to provide programming support across all programs.
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The Dean's Office administers these programs with four (4) administrators and a student services professional: the Dean, Associate Dean for Graduate Studies & Research, Associate Dean for Undergraduate Studies, Assistant Dean of Student Affairs, and Director of the MESA Engineering Program.
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Update regulatory fields in demographic data with patient choices on regulatory forms such as Notice of Privacy Practice (NPP), Advanced Directive for Health Care (ADHC), Health Information Exchange (HIE.
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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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Work closely with individual clinical teams as well as functional area partners (e.g., Translational research, Precision Medicine and diagnostics, Regulatory Affairs, Market Access, Clinical Development) to identify and implement end-to-end Data Science solutions aimed at facilitating decision making.
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Documentation follows Sharp HealthCare guidelines, professional guidelines, and meets third-party payor and regulatory requirements. Postdoctoral Psychology Fellow/Behavioral Health Therapist/Inpatient Psychology/Sharp Mesa Vista/Day Shift/Full-time 1.0.
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Are you a regulatory affairs and energy policy professional with experience in the RTOs (PJM), FERC and State Commissions? The Senior Manager/Director of Policy and Regulatory Affairs will play a pivotal role in shaping and advancing our client's strategic initiatives across PJM and regulatory landscapes.
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Strategic Security Management: Improve, develop, and execute the organization's information security strategy, aligning with business objectives and regulatory needs. Ensure compliance with legal, regulatory, and policy requirements to minimize or eliminate fines and damages.
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The Division of Business and Financial Affairs is responsible for ensuring a safe, productive campus environment while providing the highest quality service in support of academic excellence through thoughtful stewardship of financial, technological, infrastructure and human resources at San Diego State University.
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Located in Clackamas, Oregon, Penumbra specializes in various types of Information Security conformance testing and regulatory compliance. Penumbra is a Cryptographic Security Testing Laboratory (CSTL) accredited by the National Voluntary Laboratory Accreditation Program (NVLAP Laboratory Code 200983-0) under the National Institute of Standards and Technology (NIST.
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As a Senior Biologist/Ecologist, you will oversee and provide expertise in field biology, regulatory strategy, CEQA/NEPA analysis, and permitting strategy. Specific background and expertise should consist of strong botanical, wetland, or wildlife technical expertise, familiarity and experience with regulatory permitting, and project and client management.
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Prepare and provide technical review of jurisdictional delineation reports and regulatory permit applications, including Clean Water Act (CWA) 404/401, Waste Discharge Requirements (WDR), and California Department of Fish and Wildlife (CDFW) Section 1600 Lake and Streambed Alteration Agreement (LSAA.
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regulatory affairs jobs Title: intern Company: Alcorn State University in San Diego, CA
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