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Demonstrate data analysis skills and sound statistical analysis methodologies to prepare data for regulatory review (Minitab, JMP or MedStat). This person will work with other engineers and contract manufacturers to achieve project milestones including, but not limited to, design verification testing, regulatory submission and product launch of initial concepts and future iterations of the product.
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We have an exciting opportunity on our Therasphere R&D team for a Principal Software Engineer- Full Stack Web Applications Development to work in partnership with Marketing, Program Management, IT, Sales, Legal, Regulatory, and other internal stakeholders to shape franchise software strategy and lead digital product development efforts focused on enhancing customer experience.
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10+ years of information security, audit, risk, and compliance background, with demonstrated experience in the following CSF and Regulatory Frameworks including CIS, NIST, ISO, SOX, GxP, CCPA, GDPR.
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Ensures that Security Risk Analysis continues to meet evolving threat landscape and regulatory (e.g. HIPAA/Meaningful Use) requirements. Industry-recognized certifications, including Certified Information Systems Security Professional (CISSP), Certified Information Security Manager (CISM), Certified Information Security Auditor (CISA) strongly preferred.
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Reports any regulatory concerns, risk issues, non-compliance with Sonida Senior Living policies and care concerns to the QCD timely. This position also provides accurate, timely advice, consultation on risk management issues, quality indicators and regulatory matters.
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Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Abbott is seeking a passionate, experienced Regulatory Affairs Specialist II to join our team on-site in Plymouth, MN. In this role, you will perform specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for regulatory registration, ensuring products and procedures comply with regulatory agency specifications.
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Completes Resident Assessment Protocol (RAP) documentation based on regulatory requirements, MDS information obtained, and in accordance with professional standards of practice. RESPONSIBILITY: To assure timely completion of the MDS with a focus on accuracy, case mix maximization, and regulatory compliance.
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What you will Bring: Juris Doctorate degree from an accredited Law SchoolActive license to practice law, with either admission to the bar of the State of Minnesota or a limited in-house counsel license to practice law in the State of Minnesota 4+ years of in-house, law firm and/or regulatory agency experience in the areas of ethics and compliance.
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Two (2) years of advanced professional-level experience (e.g. Environmental Specialist 3 or equivalent level) in regulatory compliance, assistance or permitting. Knowledge of the overall state and federal environmental regulatory framework related to environmental emergency preparedness.
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Responsibilities Management of the Coordination with City, County, and Federal agencies to maintain regulatory compliance for entitlements and environmental issues. #CB #LI-DT1 Type Regular Full-TimeManagement of the Coordination with City, County, and Federal agencies to maintain regulatory compliance for entitlements and environmental issues.
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Support the Company’s general legal needs, including commercial and government contracts, advertising, regulatory compliance, international product distribution and litigation management. The successful candidate requires a strong background in developing and managing IP legal strategy, ideally as in-house counsel for a company in the CPG space.
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Provide legal advice and support regarding global ESG disclosure and regulatory requirements, compliance, and external reporting. You will provide legal services across a number of corporate, strategic and legal matters, including: (a) mergers, acquisitions, investments, joint ventures and dispositions, (b) corporate finance transactions, (c) SEC reporting and disclosure, (d) general corporate matters, (e) global ESG disclosure requirements and reporting.
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Facilitate communication and exchange of documents between stakeholders (e.g., internal personnel such as Regulatory Affairs, R&D Engineering, Clinical Engineering, A&P and Marketing, Library Services, Quality Engineering, Post-market Surveillance Group, Clinical Affairs, Risk Management, Program Management, as well as external vendors such as CROs, Medical Writers and Physician Reviewers.
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Accountabilities & Responsibilities:Adheres to Integer's Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.
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You will be a primary finance business partner support to PVH Quality, OU Operations, and Regulatory leadership team. Business partner to the Quality, OU Operations, and Regulatory leadership teams providing financial analysis and support that drives business decisions.
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regulatory affairs jobs Title: regulatory affairs manager Company: Jobget in Osseo, MN
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