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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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Familiarity with inventory control, OSHA, HACCP and other regulatory requirements. Discuss associate performance with Sr. Warehouse Managers and create plans to address gaps. Participate in building high-performing teams by interviewing and hiring warehouse personnel, in conjunction with Sr. Warehouse Managers.
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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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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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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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Achieves Community sales objectives and move-in goals as identified by the Executive Director and the Regional Director of Sales. This detailed plan must be refined quarterly for review by the Regional Director of Sales/Marketing.
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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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As a Sr. QA Automation Engineer at Huntington, utilize knowledge of QA best practices to plan, design, and craft and execute test solutions, primarily through automation, for various front and back end banking systems.
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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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They are accountable for execution of all applicable risk programs (Credit, Market, Financial Crimes, Operational, Regulatory Compliance), which includes effectively following and adhering to applicable Wells Fargo policies and procedures, appropriately fulfilling risk and compliance obligations, timely and effective escalation and remediation of issues, and making sound risk decisions.
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Ensuring compliance with corporate ( SOPs) and regulatory requirements ( GCP and US and OUS guidelines). Job TitleClinical Development LeadJob DescriptionAs a Clinical Development Lead on the Hospital Patient Monitoring (HPM) Clinical Affairs team, you will primarily focus on designing and supporting the execution of proactive/specific Post Market Clinical Follow-up (PMCF) activities, for HPM’s portfolio of medical devices.
$74,680 - $150,931 a yearFull-timeExpandApply NowActive JobUpdated 6 days ago
regulatory affairs jobs Title: sr director Company: Planet Pharma in Osseo, MN
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