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Demonstrated knowledge of Regulatory Affairs regulations, guidance, and procedures (Good Mfg Practice, Good Practices training programs, SOP development, and GMP audits and inspections.
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The main function of a regulatory affairs specialist is to complete and maintain regulatory approvals and clearances of assigned products. Create regulatory submissions (exercising judgment to protect proprietary information) for finalization and submission by OUS EW affiliates; track timelines and document milestone achievements, participate in developing regulatory strategy, prioritize submissions with operating plans as well as ensuring alignment with KOD in countries (e.g., OUS, (the globe minus US, EU, Canada.
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Participate in providing guidance and feedback to business unit regulatory teams on registration requirements for new and renewal registrations, product and process changes, and review of labeling content and guidance on process improvement projects, based on prior experience and responses from affiliates.
$44.6 - $49.6ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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This is Bhanu from Intellectt INC; we've got an important role Senior Regulatory Affairs Specialist - Irvine, CA with one of our prestigious clients. Role: Senior Regulatory Affairs Specialist.
Full-timeExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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We create products lines that include vegan skincare, cosmetics, and nutrition and have an immediate opportunity for a Regulatory Affairs professional with a background in Nutrition to join our team.
$72,000 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Job Description - Regulatory Affairs Specialist II - Irvine, CA. Regulatory Affairs Specialist II - 1 Year contract role. Job Description - Regulatory Affairs Specialist II - Irvine, CA.
$50 an hourExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Prin Regulatory Affairs Specialist. Minimum of 7 years of experience medical device regulatory affairs Or advanced degree with a minimum of 5 years of experience medical device regulatory affairs.
ExpandApply NowActive JobUpdated 17 days ago - UpvoteDownvoteShare Job
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The Regulatory Affairs Specialist (RA Specialist) creates, evaluates and completes regulatory tasks related to the following: worldwide product registration submissions, facility registrations, special projects and strategy to drive market growth worldwide.
$120,400 a yearFull-timeExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
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Update and develop procedures for the regulatory affairs in supporting changes in the regulatory landscape, including EU MDR. Assist the strategy implementation and operations for regulatory affairs activities, including directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
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The role of the Regulatory Affairs Specialist will be to support the global regulatory affairs of the business with a specialized focus on the United States. At least 3 years experience working in the regulatory affairs department of a medical device company.
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Reporting directly to the CEO, the Senior Regulatory Specialist is responsible for planning, directing, and coordinating global product registrations and leading regulatory submissions planning and execution; collaborating with Product Regulatory and Regional Regulatory Affairs colleagues to drive timely and accurate submission development and applications.
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Regulatory Affairs Specialist II. On behalf of our client a medical device client, we are seeking a Regulatory Affair’s specialist that will support the EU's In Vitro Diagnostic Regulation (IVDR) transition activities that will impact the company’s products currently CE Marked under the IVD Directive.
$49 an hourExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Reporting directly to the CEO, the Senior Regulatory Specialist is responsible to plan, direct and coordinate global product registrations and lead regulatory submissions planning and execution; collaborate with Product Regulatory and Regional Regulatory Affairs colleagues to drive timely and accurate submission development and applications.
Full-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Minimum of 10 years of regulatory affairs experience or advanced degree with a minimum of 8 years of experience. Works independently to provide strategic input and technical guidance on regulatory requirements for business-critical and new product development projects.
Full-timeRemoteExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Senior Regulatory Affairs Associate. Experience in doing change assessment for Regulatory Affairs. Need to have a regulatory background and hands on experience in it.
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regulatory affairs jobs Title: regulatory affairs specialist in Orange, CA
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