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This role will be responsible for leading and proactively driving clinical quality behaviors, accountability, and cross-functional collaboration (e.g. Clinical Programs, Scientific Affairs, AtriCure Quality, Regulatory Affairs, Medical Directors, Study Teams, Investigational Trial Sites, and external vendors) with respect to clinical quality assurance activities.
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Hiring Agency/Seniority Unit: Minnesota Department of Veterans Affairs/ Veterans Home-Minneapolis-MNA. To be considered, you must be included on a US armed forces permanent disability list with a disability rating of at least 30% or been rated by the US Department of Veterans Affairs as having a compensable service-connected disability of at least 30.
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With the guidance of a regulatory specialist, prepare study documents and applications for IRB submission, obtain regulatory (IRB and ancillary review) approval, submit study modifications, continuing reviews, RNIs, and ensure studies retain regulatory approvals.
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The TeamThe Marketing and Engagement Team (MET) is comprised of the following departments: Annual Fund, Global Connections (Major Gifts), Partnerships & Government Affairs, Marketing & Communications, Donor Services, and Operations.
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Communicate frequently with other Respiratory Sales Specialists across the country and cross-functional counterparts such as Marketing, Sales Ops, Market Access, Field Reimbursement, Training, and Medical Affairs to create alignment of business plan, focus on strategic drivers, and sharing best practices.
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Provides tactical guidance and functional support in transactions and daily work, and ensures that all compliance activities are consistent with legal and regulatory requirements, as well as CoBank policies and procedures.
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The Property Manager will be responsible for the lease-up of a new construction building and managing day-to-day operations of properties, including marketing and leasing: rent collection; supervision of site staff, maintenance staff, and caretakers; budget management and property conditions; maintaining positive relations with neighbors, funders, regulatory agencies, and both internal and external PPL customers, all with an elevated level of customer service.
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Understanding of electrical system elements including wiring harnesses, printed circuit board assemblies (PCBAs), and regulatory testing (UL, IEC, EMC, ESD, EFT). Experience driving development of electrical components based on defined interfaces, system, regulatory, and performance requirements.
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Must have a strong understanding of a firm back-office and financial reporting functions such as reserve formula, FOCUS report, possession and control, stock record, general ledger, trade blotters, margin requirements, time critical regulatory functions (e.g., buy-ins, sell outs), record retention, access control procedures, and cybersecurity.
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For vetted proposals and using approved templates, provide support for regulatory activities including initiating the study start up by drafting a protocol and preparing supporting documents for the Institutional Review Board (IRB) submission, filing for protocol amendments, facilitating approvals, study reviews, and closures.
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The Sr. CRC would be expected to work independently to coordinate clinical research studies according to regulatory requirements, institutional guidelines, and sponsor expectations. Duties are determined by protocol-specific requirements and may include initiating new trials, screening patients for eligibility, coordinating the enrollment of eligible patients, extracting and reporting accurate patient data, managing lab samples/specimens, responding to data queries, overseeing the study progress, and assisting with regulatory tasks.
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As a member of the Scientific Affairs team, the role will report to the Manager, Global Registries, and collaborate closely with vendors, site research staff, Clinical Operations, and Data Management teams at AtriCure.
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Demonstrated experience with state and federal agencies such as the US Fish and Wildlife Service, state wildlife agencies, US Army Corps of Engineers, Bureau of Land Management (BLM), US Forest Service, and the Federal Energy Regulatory Commission (FERC.
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Classification Title MnSCU Academic Exam Monitor Working Title Nurse Aide Skills State Testing Evaluator Hire Types Staff Division Hennepin Technical College Department Academic Affairs Unit Industry Location Eden Prairie/Brooklyn Park FLSA Non-Exempt Full/Part Time Intermittent FTE Employment Condition Intermittent Work Shift Variable Work Schedule/Hours/Days.
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The Senior Financial Analyst will serve as the Solid Organ Transplant primary internal consultant responsible for providing critical analytical support for regulatory and financial implications of the Transplant components of the Medicare Cost Report (MCR.
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regulatory affairs jobs Title: regulatory affairs manager Company: Gpac in Mounds View, MN
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