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This role collaborates cross-functionally with key cross-functional partners including other GMA functions, Clinical Development/Operations, Regulatory Affairs, Corporate Communications/IR, Legal, Market Access and Commercial, and Research.
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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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Works with Manager of Legislative Affairs to draft, develop and manage the legislative process for all required department-initiated legislation for Grants, Contracts, Real Estate and other legislative needs, and may directly manage at least one of these portfolios.
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Participation in the seasonal influenza vaccination program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP). The Department of Veterans Affairs performs pre-employment reference checks as an assessment method used in the hiring process to verify information provided by a candidate (e.g., on resume or during interview or hiring process); gain additional knowledge regarding a candidate's abilities; and assist a hiring manager with making a final selection for a position.
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Provides strategic expertise in regulatory processes, laws and regulations at the federal and state levels of government. 8 years of experience in government relations, public policy, advocacy or public service with a direct connection to the health care industry.
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Supports the Director, Regulatory Law, Government Affairs and Trade Compliance in managing risk within the defined scope of responsibility. Reports to: Director, Regulatory Law, Government Affairs and Trade Compliance.
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The Senior Regulatory Affairs Specialist provides regulatory guidance to cross-functional teams; develops global regulatory strategies; advises on labeling and marketing materials for regulatory compliance; and evaluates product changes for impact on regulatory filings worldwide.
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Resolve complex, escalated compliance issues within Quality Assurance and Preclinical/Clinical Operations, Regulatory Affairs, Medical Affairs, Biostatistics, Data management and Pharmacovigilance.
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Reporting to the Senior Vice President, Global Regulatory Affairs, this key senior leadership role serves as a recognized regulatory policy leader and influential spokesperson in support of Amgen’s global regulatory initiatives.
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The Scowcroft Institute of International Affairs, in the Department of International Affairs, Bush School of Government & Public Service at Texas A&M University is recruiting up to 2 Research Assistant Professors (nontenure track) full-time, nine-month positions with the earliest possible start date beginning in Spring 2024 and the positions have the possibility of renewal.
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Within HPDs Office of Legal Affairs, the Regulatory Affairs Division (RAD) provides legal support services for the Agencys regulatory and enforcement functions and advice on compliance with external City, State, and Federal statutory and regulatory requirements.
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Then come and join our global team as Regulatory Affairs Specialist to support international registrations. As a Regulatory Affairs Specialist, you will be responsible for : Preparing, submitting, and managing regulatory applications required for product market approvals in global market.
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C. The Dean of Instruction coordinates most closely with the Vice President for Academic Affairs and Student Services, Dean of Academic Innovation and Instructional Technology, Dean of Planning and Institutional Effectiveness (PIE), Dean of Workforce Solutions and Continuing Education (WSCE), Dean of Student Affairs, the Vice President for Administration and Finance, the Senior Director of Information Technology, and the Academic Division Directors.
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Serves as the principal liaison to other MGB and Mass General hospital departments and services such as: Patient Care Services; Network Development; Marketing; Office of General Counsel; Development; Public Affairs and Communications; Research Management; Budget and Finance, etc.
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The PharmaDx Regulatory Affairs Specialist I supports the development and submission of lab developed tests and companion diagnostics (class III medical devices) to the FDA and other global regulatory bodies for in vitro diagnostic (IVD) approval and/or performance of clinical trials.
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regulatory affairs jobs Title: assistant Company: Department Of Veterans Affairs
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