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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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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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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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Familiarity with inventory control, OSHA, HACCP and other regulatory requirements. Discuss associate performance with Sr. Warehouse Managers and create plans to address gaps. Drive associate engagement and retention, and create a culture that embodies US Foods values.
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IC Design Senior Engineering Manager Job Description
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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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Job DescriptionWhat to expect when you work hereAs a Sales Associate, you would be responsible for providing every customer with a great experience. Exciting opportunities to represent Cycle Gear at special eventsInternational Motorcycle Show, motocross races, etc.
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Knowledge of the insurance industry and the legal and regulatory environment. Zurich North America is hiring a RCIS Crop Underwriting Account Service Associate to join the Crop Underwriting team in Anoka, Minnesota.
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Along the way, we help every associate grow their career and achieve their best, at work and in their community. Experience in one or more of the following is preferred: washing, waxing, cleaning and buffing, masking, sanding, grinding and applying paint; removing and replacing small parts, carrying out minor repairs.
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It includes verification and validation, environmental, performance, reliability and safety/regulatory related tests and executing the same, documenting the reports. Hands on Experience in IEC basic safety, EMI-EMC standards.
$80,000 - $110,000 a yearFull-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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As a Sr. Advanced ASIC Design Engineer, you will be responsible for providing customer technical support for Honeywell's Space Microelectronics portfolio of Radiation-Hardened ICs. This includes supporting products, processes, and technologies in alignment with the organization's business strategies.
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Experience performing disinfection testing including knowledge of disinfectants, regulatory knowledge and experimental design, to demonstrate the disinfection efficacy for demonstrating product safety for reusable medical devices.
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Benefits include: Associate discount; EAP; smoking cessation; bereavement; 401(k) Associate contributions; child care & cell phone discounts; pet & legal insurance; credit union; referral bonuses.
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regulatory affairs jobs Title: sr regulatory affairs associate Company: Thermo Fisher Scientific in Osseo, MN
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