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The Regulatory Affairs Manager will work out of our Maple Grove, MN location for our Electrophysiology division. Regulatory Affairs Manager - Electrophysiology page is loaded.
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The Regulatory Affairs Specialist will develop strategies and submissions for projects and issues related to regulatory documents, global submissions, investigations, product development planning, and regulatory agency interaction for blood products and biologics.
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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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Support the Companys 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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Environmental Regulatory Compliance - Champions compliance with environmental regulatory requirements imposed on the industry by local, state, provincial, national, and international organizations including air emissions, wastewater discharges, natural resource consumption, waste generation, spill prevention and reporting, and emergency response.
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Assist facilities management team in ensuring required regulatory permits are acquired, required reports are submitted to regulatory agencies and any site permit conditions (e.g. recordkeeping, process safety management (PSM), stormwater, special waste, etc.
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Providing advice and counsel to all business and corporate teams located in the U.S. on the Code of Conduct, anti-bribery, antitrust and other regulatory matters. 4+ years of in-house, law firm and/or regulatory agency experience in the areas of ethics and compliance.
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Adheres to Integer Core Beliefs and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.
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The Assistant to the Vice President and Deans provides confidential administrative support and assistance to the Vice President of Academic and Student Affairs, Dean of Academic Affairs, Dean of Community Partnerships and Student Success, and approximately 125 faculty.
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Experience as a Program Manager at Medtronic or medical device industry in Clinical Research or Clinical/Medical Affairs, Regulatory, Quality, Engineering, Health Care. Work across the Medtronic Clinical and Regulatory enterprise and adjacent functional partners by offering a variety of services: Program & Project Management, Process Improvement, Value Stream Excellence, Project Management Training & Coaching, Strategic Planning Facilitation, Council/COE Facilitation, Kaizen Facilitation, and MPS/Green Belt coaching.
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Experience in clinical research and regulatory affairs, specially related to the launch of high complex technology in US and OUS. The Clinical Leader will provide integrated, strategic clinical research & medical science input to the OU Leadership Team and serve as a clinical resource for navigating through the complexities of the regulatory approval process and post-market surveillance, e.g. well-versed in the requirements of the European Medical Device Directive and US FDA PMA and 510(k) processes.
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Administer the process of applying for permits related to mining activity, including coordination with management, legal staff, and local/state regulators, across all regulatory programs, including air quality, water rights, process and stormwater discharge, Army Corps/WACA/TEP/LGU floodplain and wetlands, and endangered species.
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Interface with regulatory bodies (OSHA, DOT, EPA, and State/Local Regulators). Monitor, interpret and communicate regulatory changes to Operating Company (OpCo) management. Considerable experience with occupational safety, transportation safety, and environmental compliance preferred.
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regulatory affairs jobs Title: sr director Company: Csl Behring in Osseo, MN
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