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Recruiter: Spencer Gregory Hale Regulatory Affairs Manager - Core CRM Sustaining Program Regulatory POC Team Purpose: The Rhythm Management (RM) Regulatory Affairs leadership team is a strategic partner that delivers innovative, efficient, and sustainable business and regulatory solutions for customers throughout the product lifecycle.
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The Corporate Audit Services (CAS) Senior Audit Manager - Wealth, Commercial, Capital Markets is a senior level management position that supports the Regulatory Compliance Audit Director/Senior Audit Director of the Risk Management and Compliance audit team.
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Conducts and oversees Internal Affairs Investigations (IA), under the direction of the Chief of Police or as assigned by VHA Leadership. Participation in the seasonal influenza vaccination program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP.
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This position reports to the Director, Global Partnerships and Government Affairs and will also work in collaboration with CMEO and CEO to define effective strategies for corporate and foundation partnership engagement.
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POSITION SUMMARY:The Clinical Research Associate II (CRA II) will be a key contributor to AtriCure’s clinical affairs department and primarily responsible for the site management of assigned clinical investigative CRA II will assist with the implementation and execution of study protocols and associated study documents for clinical trials, including clinical monitoring of AtriCure also includes the coordination of site activities from site start-up to site closure as needed.
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Tasks may include conducting and/or overseeing wetland delineations, inventories, and functional assessments; performing botanical and wildlife surveys; developing permit applications; planning wetland mitigation projects (including construction oversight); preparing environmental impact assessments; and negotiating with regulatory agencies.
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Demonstrates extensive knowledge of, and/or a proven record of success performing in a role that emphasizes analyzing client internal control practices and evaluating client compliance with import control regulatory requirements, and some knowledge of international trade and US Customs issues, such as:Associated documentary requirements;Knowledge of the analysis of client internal control practices; and,Knowledge of valuation of client compliance with import control regulatory requirements.
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Advanced understanding of applicable laws, regulations, and regulatory trends that affect financial services industry and model risk management. The CAO Chief Risk Office (CRO) team works with internal risk partners and business units across CAO as well as enterprise groups (Model Risk Management, FRBD, Audit) to identify and manage model risk.
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Contribute to the preparation and review of CMC (Chemistry, Manufacturing, and Controls) documentation, particularly focusing on the analytical sections required for regulatory filings(BLA/MAA), including post-approval submissions to US and EU regulatory bodies.
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As a critical member of a cross-functional deal team, lead the conduct of legal due diligence, develop, and negotiate key deal terms, draft asset purchase and other agreements of varying complexity, ensure compliance with regulatory and other requirements, and manage post- closing integration and other activities.
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Experience in a pharmaceutical, Federal Drug Administration (FDA), other controlled regulatory agency or Current Good Manufacturing Practices (cGMP) packaging or manufacturing environment is preferred.
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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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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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The Market Access Regional Reimbursement Manager (MARRM) is pivotal in supporting the US Market Access Department's mission to ensure patient access to best-in-class technologies and products for Advanced Wound Management, including Grafix, Oasis, and PICO. The MARRM will focus on government payers (such as Medicare, Medicaid, and Veterans Affairs) and regional commercial payers in executing company goals.
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Reporting to the General Counsel, this position is responsible for providing proactive and pragmatic legal counsel to Great Clips, Inc. on a variety of issues, including legal obligations involving franchise regulatory matters, commercial real estate transactions, and franchise relationships.
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regulatory affairs jobs Title: director Company: Planet Pharma in Brooklyn Center, MN
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