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Academic Affairs and Human Resource Manager. General Neurology, Alzheimer's Disease and other Dementias, Epilepsy, Movement Disorders, Multiple Sclerosis, Cognitive Neurology, Neuroepidemiology, Neuromuscular Disease, Neuro-Oncology, Neuropsychology, Quantitative Brain Imaging, Pain Management, Sleep, Experimental Therapeutics, Biomarkers and Precision Medicine, and Stroke.
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In addition, the Clinical Affairs Program Manager will perform annual activities associated with Post Market Surveillance (PMS) program, including but not limited to, preparing and writing plans, reports and Post Market Clinical Follow-up (PMCF.
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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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Knowledge of state and federal environmental regulatory framework, including the National Environmental Policy Act (NEPA), National Historic Preservation Act, and the California Environmental Quality Act (CEQA.
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Manage and provide legal advice and legal services relating to government/regulatory litigation, patent litigation, warranty (lemon law) and other types of litigation, as needed. Also responsible for supervising litigation attorneys and paralegals in providing in-house legal services on warranty laws (lemon law claims, lawsuits, subrogation matters) and related consumer affairs and customer service issues and handling these issues directly.
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The Clinical Affairs Program Manager will be responsible for the development and generation of Clinical Evaluation Plans and Report (CEPs, CERs), clinical literature searches analysis of clinical literature, and evaluation and review of clinical data, generated both pre and post-market for medical devices and in vitro diagnostic devices.
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The candidate will work on a wide range of regulatory, administrative, transactional, and litigation matters relating to the development of land and natural resources, and in the specific subject matter areas of project development, CEQA and NEPA, public lands, and mining, air, water, and energy.
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Advise clients on regulatory matters, including Stark Law, Anti-Kickback Statute, and HIPAA compliance. Lead and manage complex healthcare revenue cycle litigation cases, including disputes with payers, regulatory agencies, and vendors.
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In addition, the incumbent is the key regulatory contact for Quality, Medical Safety and International Regulatory Affairs colleagues. The Associate Director of Regulatory Innovation supports regulatory objectives for Allergan Aesthetics products including coordination, management of global submissions.
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Must have 2 years experience with planning, executing, monitoring and reporting of activities for FDA regulatory compliance projects of GxP systems; Performing Root Cause Analysis for deviations from process and agreed metrics; Performing risk management; Working with GxP, GAMP, GDP, 21 CFR Part 11, Annex 11, CSV, CSA, FRA, Risk Based Validation.
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Regulatory Compliance: Stay up-to-date with FDA regulations and injection molding standards applicable to medical device manufacturing. Prepare comprehensive reports for regulatory compliance.
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Strong technical and regulatory working knowledge of CEQA/NEPA assessment criteria, air district rules and regulations, and state and federal regulatory programs; Proven track record of successful compliance work in dealing with various lead and regulatory agencies.
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This candidate will primarily assist with regulatory compliance efforts for federal, state, and local environmental projects in CDM Smith’s portfolio, with focus on fisheries science, protected species, floodplains and wetlands, stream and habitat assessments, and associated permitting tasks.
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The incumbent is also responsible for maintaining communication with all elements of a multi-level research network, including attending Disease Oriented Teams (DOTs) meetings, interacting with sponsoring agencies including National Cancer Institute, and compliance and regulatory groups such as the Institutional Review Board (IRB), Food and Drug Administration (FDA), and sponsor monitors.
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Conducts frequent crew visits and field observations to ensure crews have the appropriate tools and resources to perform the work, monitor progress, and ensure work is completed to regulatory and SCE standards.
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regulatory affairs jobs Title: sr regulatory affairs associate in Costa Mesa, CA
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