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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. Direct: Union and/or non-union warehouse on-floor associates (Loaders, Selectors, Receivers, Forklift drivers, etc.
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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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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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Riverway Clinics has an exciting full-time opportunity for a full-time Medical Lab Technician (MLT), Certified Medical Assistant or Registered Medical Assistant to work in the laboratory department at our Anoka location.
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Medical Assistant Who We AreWe are a team that is focused on patient care and quality. Behavioral Health Group (BHG), is a leading provider of opioid addiction treatment services. At BHG, we are committed to the belief that addiction is a brain disease, not a moral failing.
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The Press Assistant is responsible for efficient make-ready of jobs to meet the needs of the press schedule, clean-up, receiving, documentation, proper handling and storage of press components such as ink pots, dies, print cylinders, rollers, plates & supplies.
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You love working with animals and people.
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We are looking for a Server/Culinary Assistant to join our team! This nutrition services schedule includes; casual / on callCash Out Wages Before Payday with our New Benefit of Early Wage Access: Amira Choice Champlin features a full range of living options, a full schedule of activities and programs, as well as the comfort and security of full-time, around-the-clock caregivers for personalized care.
$16 - $22Full-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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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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This may include job cost quantities, regulatory reporting requirements, payroll reports (timecards), truck quantities, approval of vendor invoices, safety reports, daily logs, and other documentation.
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regulatory affairs jobs Title: regulatory affairs assistant Company: Jobget in Osseo, MN
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