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This role reports to the Senior Manager of Quality and Regulatory Compliance within the IC/SP business unit. Respond to internal and external customer and/or regulatory compliance requests.
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Our suite of services is designed to cater to a broad range of needs of healthcare organizations, including healthcare IT innovation, electronic health record (EHR) implementation & optimizations, data conversion, regulatory and quality reporting, enterprise data analytics, FHIR interoperability strategy, payer-to-payer data exchange, and application programming interface (API) strategy.
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Harmonized facility maintenance procedures and practices to cover critical systems such as HVAC, sanitization, security, safety program, metrology, preventative/predictive maintenance program, contract services, environmental permitting, critical facility documentation, space planning, facility asset management (excluding IT related assets), building and maintenance monitoring systems in compliance with local and federal regulatory authorities such as: OSHA, state permits, FDA, EMA, etc.
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Partner closely with the CMC, Regulatory, and Quality teams to ensure smooth transition from process validation to routine commercial manufacturing. Represent Global Labeling on product-specific Regulatory and Cross-Functional teams, as appropriate.
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We are looking for you to join our team as a Principal/Sr. Principal SEIT (Systems Engineering Integration and Test) Lead based out of Sunnyvale, CA. This role is part of a production team supporting marine propulsion and power generation machinery.
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Solid understanding of data governance principles, regulatory compliance (e.g., GDPR, CCPA), and best practices in data management. - Stay current with industry trends and advancements in data management, analytics, and regulatory compliance.
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We’re interested in working with people that have developed and maintained accurate accounts of company affairs and have managed investor reporting requirements. 5+ years of experience in one or more of the following areas: equity research, investment banking, investor relations, or management consulting.
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Collaborate with regulatory affairs to ensure compliance with applicable medical device regulations and standards throughout the development lifecycle. Define project requirements, specifications, and timelines in collaboration with cross-functional teams, including engineers, researchers, medical professionals, and regulatory specialists.
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Duties: provide cardiac catheterization, transaortic valve replacement, and electrophysiology procedure services on site in accordance with specifications contained herein to beneficiaries of the Department of Veterans Affairs (VA) located at the VA Palo Alto Health Care System.
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We are the family office of an ultra-high net worth individual dedicated to managing the personal and financial affairs and philanthropic endeavors of our principal. We are seeking a talented and experienced attorney to join our team in the role of Counsel supporting the General Counsel in both traditional (grantmaking) and mission aligned investing/venture philanthropy matters.
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The Director of CMC Analytical Development's responsibilities will be:Create and put into place CMC analytical strategies to assist with drug development and regulatory submissions. Prepare and review CMC analytical sections of regulatory submissions, including IND, BLA, NDA, and MAA.Prepare for and develop data-driven responses to regulatory requests for information related to analytical activities.
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Support Regulatory, Safety Compliance, Preventive Maintenance, and Calibration Programs. Must have a working knowledge of cGMP, SOPs, HVAC, refrigeration, Specialty Water Systems, electrical, Gas Delivery Systems, pumps & drives, and chemical treatment equipment operation and maintenance.
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Consistently ranked as number one in the space, NICE Actimize experts apply innovative technology to protect institutions and safeguard consumers and investors assets by identifying financial crime, preventing fraud and providing regulatory compliance.
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Understanding of regulatory standards and compliance requirements for air quality monitoring, particularly related to EPA and USGS projects. The Associate Data Scientist will collaborate with a diverse group to design, build, maintain air quality sensors, and analyze air quality data for the EPA, USGS, and other stakeholders.
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Apache Spark is a multi-language engine for data engineering, data science, and machine learning that lies at the core of our initiatives.
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regulatory affairs jobs Title: sr Company: Csl Behring in Menlo Park, CA
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