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As well as financial services regulatory requirements (CCPA, PCI-DSS, etc.) You will work with the Data Security team to reduce the risk for the organization by securing data through detection of sensitive data, classifying and labeling detected data, and applying encryption or other security controls to protect and ensure appropriate access to and use of sensitive data to fully comply with all applicable laws and regulatory guidance.
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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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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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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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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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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 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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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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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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Builds and maintains relationships with relevant stakeholders including Regulatory Affairs functional areas, Precision Medicine, Medical Affairs and Commercial organizations. The Manager, Regulatory Affairs In Vitro Diagnostics and Companion Diagnostics works with internal and external partners to develop and implement global regulatory strategies for In Vitro Diagnostics (IVD)/Companion Diagnostics (CDx) to support business objectives.
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Experience with AERMOD, GIS and/or health risk assessments for permitting, ambient monitoring or emissions sampling techniques, CEQA, or other regulatory compliance programs (e.g., SPCC, RMP/PSM, stormwater) is a plus.
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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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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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Stay abreast of changes in legislation and regulatory requirements impacting the debt settlement industry, assess their potential impact on our operations, and develop and implement strategies to maintain compliance.
$190,000 - $210,000 a yearExpandApply NowActive JobUpdated 4 days ago
regulatory affairs jobs Title: sr regulatory affairs in Irvine, CA
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