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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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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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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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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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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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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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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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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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Identify optimal reimbursement pathways for portfolio pipeline (coding/coverage/payment) Collaborate with new product development teams and clinical/regulatory colleagues to ensure health economics and market access needs are incorporated into product development plans, clinical trials and regulatory strategies Participate as contributing member on cross-functional evidence planning teams.
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Serve as cross-functional leader on PLM organizational, process and design considerations (e.g., R&D, Quality, Regulatory, Operations). Design and execute the Product DNA strategy to deliver on the program’s key objectives by partnering closely with key stakeholders across the enterprise including but not limited to, R&D, Regulatory, Quality, Operations, Commercial Operations, etc.
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Regularly interact with the Regional Environmental Manager (REM), regulatory agencies, and division associates. Regularly interact with and assist division associates to achieve storm water and air quality regulatory compliance.
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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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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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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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Demonstrate skill in documentation that meets all regulatory and DBT-PTSD standards. Fully licensed as a clinical mental health professional in Minnesota (LCPC, LPC, LMFT, or LMHC) Ideally, this individual has had exposure to other trauma modalities such as EMDR, ART (accelerated resolution therapy), AIR (adaptive internal relational) Network, Prolonged Exposure, or Somatic Experiencing.
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regulatory affairs jobs Title: assistant Company: Veterans Affairs Health Administration in Osseo, MN
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