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With minimal oversight, the Pr. Regulatory Affairs Specialist (PRA) for the European Union Medical Device Regulation (MDR) will be responsible for supporting execution to MDR compliance plans to ensure all applicable technical files (for devices ranging from class I to class III) meet the EU MDR requirements on schedule.
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Provide legal counsel to Abbott’s Electrophysiology team on compliance, risk management, and other legal issues in the context of federal and state regulatory requirements, including those relevant to sales and marketing of products to health care professionals and reimbursement by government programs areas, for example, fraud and abuse (Anti-Kickback Statute, False Claims Act), FDA regulation (Food, Drug & Cosmetic Act), privacy (HIPAA), and anti-corruption (Foreign Corrupt Practices Act.
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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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Leads and directs the site Quality function to assure successful new product design transfer and post-market surveillance by collaborating with the Operations, R&D, NPI, Commercial, and Regulatory functions.
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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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Familiarity with inventory control, OSHA, HACCP and other regulatory requirements. Regularly inspect facility for safety hazards and either resolve them or report them to the safety manager as appropriate.
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Our team is looking for a Project Manager for its Champlin, MN office for a permanent & full-time position. Annual bonus based on Project Manager Bonus Program; Apply now for the Project Manager position.
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Leveraging your strong technical background in chemistry, chemical engineering, and/or environmental engineering and with a proven track record in designing and implementing water purification systems using the latest technologies, you will work closely with cross-functional teams to deliver innovative solutions that exceed expectations and ensure compliance with regulatory standards.
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IC Design Senior Engineering Manager Job Description. Proven track record of leading teams to successful project delivery. You will use your leadership skills to motivate teams that are designing digital ASIC, FPGA and mixed-signal integrated circuits, and associated processes.
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For the first few months of this position, the Clubhouse Manager will work with Vail Place staff to develop relationships with partners in Ramsey County and with potential members, to shape the culture and community of the Ramsey County Clubhouse, and to make the grand opening of the Clubhouse a success.
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Manage and mentor a team of 10 software developersCollaborate (or monitor collaborations) with OEM customers, factory manager, and product managers to define features and establish schedules and roll out plansAssist with architectural decisions on productsContinue and refine our excellent software process practicesManage and execute project plans in a high paced, professional, highly collaborative multi-disciplinary engineering environment.
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Accountable and Reports to: District Store Director, Store Manager, Assistant Managers of; Store Operations, Perishables, and Health Wellness Home; Night Stock Department Manager. Job Title: Assistant Night Stock Department Manager.
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Highway/Heavy Civil Construction Assistant Project Manager/Estimator. The Assistant Project Manager provides business and construction management support to facilitate the planning and executing of the activities of a designated project or projects to ensure that the project objectives are accomplished within the prescribed schedule and funding parameters.
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Participate in audit preparation activities for/or interactions with regulatory agencies (FDA, BSI, etc.) This person will work cross functionally with Anteris engineers to ensure Anteris, and external regulatory requirements associated with manufacturing controls are met and sustained.
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Work daily with the fabrication supervisor, operations manager and the scheduler on status of orders as needed. Work daily with the fabrication supervisor, operations manager and the scheduler on status of orders as needed.
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regulatory affairs jobs Title: regulatory affairs project manager Company: Gpac in Osseo, MN
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