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Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Senior Regulatory Affairs Specialist. The Senior Regulatory Affairs Specialist will be responsible for developing strategies to obtain FDA clearance or approval of new Class II & III cardiovascular medical devices and improvements to existing devices.
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Be passionate about Regulatory Affairs impact in support of the research, development, clinical, marketing, and production of state-of-the-art class III cardiovascular medical devices. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.
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The Associate Director of Regulatory Operations is responsible for the assembly, publishing, QC, submission, and archiving of regulatory filings to global Health Authorities (HA) in an efficient and timely manner.
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Review audits and ongoing monitoring of DEA compliance, FDA compliance, PDMP compliance, OSHA compliance, HIPAA and HITECH compliance, and Boards of Pharmacy regulatory compliance, and compliance with client KPIs. Partner with the CCO to the design and maintenance of quality programs, including but not limited to QA plans, inspection procedures, work instructions, training, deviation investigations and CAPA management, facility mapping and validation projects.
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FA Sr. Regulatory Analyst- Advance Air Mobility (AAM)/UAS Traffic Management (UTM) Support the UAS Support Center Help Desk summarizing and analyzing public comments, researching aviation and other regulatory issues, supporting special projects, working with Government and industry personnel, and conducting Internet research.
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The Analyst II - Policy & Regulatory Operations is responsible for Local, State, Federal, contractual and accreditation requirements interpretation, gap analysis, project scope develop and initiation, resource planning, risk identification and project implementation, as well as timely comprehensive review and maintenance of internal and Provider policies.
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Provide expert legal counsel on Crypto and Digital Assets transactions and regulatory issues. A law firm in New York City is seeking a seasoned Regulatory Practice Partner to provide strategic legal advice and support in Crypto and Digital Assets transactions and regulatory matters.
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The right candidate will have a basic understanding of and enthusiastic belief in the cryptocurrency/digital asset space, 12+ years of relevant litigation and regulatory experience at a top law firm or in-house at a fast-paced, brand-name business, and possess strong academic credentials and excellent writing and analytical skills.
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Provide legal support in filings, research, and regulatory compliance for FERC matters. A law firm in Denver, CO, is seeking an experienced Regulatory FERC Attorney with a strong background in federal and state laws and regulations, specifically in FERC proceedings involving electric matters.
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POSITION SUMMARY Reporting to the Managing Counsel, Health Affairs, Privacy & Data Protection Law, the Principal Counsel - Health Regulatory provides primary legal support to the University's medical centers and health sciences schools on complex and high impact healthcare regulatory analysis.
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The Senior Regulatory Specialist will work within and help manage interdisciplinary teams supporting federal government client agencies that develop and implement regulatory programs affecting the environment, energy, homeland security and immigration, labor and workforce issues, public health, nutrition, transportation, and other national priorities.
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Work with clinical teams to develop and maintain division wide regulatory and compliance programs, including service directors, clinical genomics analysis team, clinical laboratories, preanalytical team, and NGS Analytics team.
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In partnership with the Global Regulatory Product Team (GRPT), the RSW Associate Director and his or her direct reports drive the compilation and preparation of critical global strategic regulatory documents articulating the scientific justification of company positions and relevant knowledge for submission to global health authorities.
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The individual will be responsible for performing duties necessary in the implementation of the SC underground storage tank regulatory compliance program and to support the UST Management Division.
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Providing overall leadership and direction to the Quality Assurance and Regulatory Affairs McKesson 3PL Team. The Senior Director, QARA is principally responsible for the development and implementation of the Company’s quality assurance program through the development and implementation of quality assurance and compliance standards via policies and procedures, training, auditing and monitoring, facilitating internal reporting, compliance-related investigations, and keeping Third Party Logistics VP of Quality Assurance & Regulatory Affairs informed on quality assurance and regulatory affairs matters.
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Title: regulatory Company: Clarivate Plc
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