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Develops local language materials including local language Informed Consents and translations | Interacts with IRB/IEC and Regulatory Authority for assigned protocols. Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities in submission and approval related interactions.
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Knowledge of ICH GCP, IRB/IEC, and local regulatory authority drug research & development regulations. Performs an array of assigned duties including investigator site recruitment/feasibility; essential document collection and review; ICF review; study document/plan development and review; maintenance and close-out of in-house site management activities in accordance with the protocol; review and compliance with standard operating procedures (SOPs); ICH/GCP guidelines and all applicable regulatory requirements.
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In depth knowledge performing risk management per ISO In depth knowledge in developing and testing products to IEC- Safety standard In depth knowledge in developing and testing products to IEC EMC standard Requirements: BS degree in engineering Understanding of US and international regulatory requirements for medical devices strongly preferred Experience developing reliability plans.
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Ability in reviewing documents and parts according to ASTM, PED, IEC, ASME, CE, CSA, UL other international standards & Regulatory Requirements. Ability in reviewing documents and parts according to ASTM, PED, IEC, ASME, CE, CSA, UL other international standards & Regulatory Requirements.
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Strong working knowledge of Maritime Regulatory Authorities (i.e. ABS, NAVSEA, MIL, USCG, IMO, etc.) Thorough knowledge of IEEE standards, ABS rules, IEC standards, SOLAS, Military Specifications, and/or NEC.
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Authors, reviews, and edits documents related to trials, such as monitoring plans, SAPs, amendments, IRB/IEC submissions and regulatory submissions. ยท Authors clinical sections of communications/documentation for regulatory agencies and may participate in meetings as needed; Conducts detailed literature reviews and analysis of development opportunities from mechanistic, pharmacological and clinical development perspectives.
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Authors, reviews and finalizes the medical and scientific portions of protocol synopsis and clinical study protocols and amendments; Reviews and edits documents related to trials, such as monitoring plans, SAPs, amendments, IRB/IEC submissions and regulatory submissions.
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The Clinical Operations Manager | Regulatory is accountable for achievement and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, policies and procedures, quality standards and adverse event reporting requirements internally and externally.
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Champion, expert, and technologist of global enveloping IEC Standards based Digital Systems and Software Process Engineering (DS&SPE) governance program and its implementation throughout EngineerProcureConstruct (EPC) project lifecycle.
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10 years of experience with International Atomic Energy Agency (IAEA) Safety Guides and referenced IEC Standard 61000 series [e.g.; 61513 Nuclear power plants - Instrumentation and control important to safety - General requirements for systems, 61508 Functional Safety of Electrical/Electronic/Programmable Electronic Safety-related Systems (E/E/PE, or E/E/PES.
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This position will beresponsible for creating and applying image quality metrics and conducting performanceevaluations for the vascular lab modalities to a) support validation, benchmarking, andoptimization of products, b) provide scientific support to help successfully clear products andproduct claims through FDA and other regulatory bodies, and c) aid clinical research at Canonluminary sites with physics-based and data science-based image quality assessment.
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Leads and is accountable as champion, expert, and technologist of the global enveloping IEC [and Canadian] Standards based Digital Systems and Software Process Engineering (DS&SPE) governance program specific to real-time process computing systems and components or equipment and its implementation in the standard plant design and throughout the lifecycle of all customer site specific design Engineer-Procure-Construct projects.
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3 years of experience with US Nuclear Regulatory Commission (NRC) Regulatory Guides (Reg Guides) and referenced IEEE Standards [e.g.; 603 Criteria for Safety Systems for Nuclear Power Generating Stations.
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Lead joint GEH and customers technical working group (TWG) for IEC Standards based DS&SPE governance program and the implementation of it on all products or projects in which it is invoked. 5 years of experience with Canadian Safety Commission (CNSC) Regulatory Documents (REGDOCs) and referenced CSA Standards [e.g.; N290.14 Qualification of digital hardware and software for use in instrumentation and control applications for nuclear power plants.
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Utilize resources available for safety and regulatory standards (IEEE, IEC, NEC, NESC, NERC, ISO/RTO) to effectively define project requirements, review project deliverables (physical, P&C, power system design) and collaborate with owner and OEM resources (subject matter experts, internal engineering, and project management.
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