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The Regulatory Affairs Specialist is responsible for preparing Nutritional Facts and Ingredient Statements (reg sheets) for all products within the Bimbo Bakeries USA (BBU) organization, including private label brands and foodservice.
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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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Principal Regulatory Affairs Specialist- Software & Artificial Intelligence (U.S. Hub Based) The Principal Regulatory Affairs Specialist- SW & AI will shape, lead and execute innovative regulatory strategies to drive innovation within the Philips Innovation and Strategy organization globally.
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The Regulatory Affairs Specialist will develop strategies and submissions to support Teleflex Medical’s Anesthesia and Emergency Medicine business unit. Regulatory Affairs Specialist.
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The Principal Regulatory Affairs Specialist will be part of this high-performance team and responsible for developing regulatory strategies, preparing U.S. and major market submissions and obtaining approval to introduce new spinal implants and biologics worldwide.
$150,801 - $207,351 a yearFull-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Bachelors degree in engineering (Biomedical, Chemical, Mechanical, Software/Computer, Electrical), science, or technical discipline with coursework in Regulatory Affairs/Quality Engineering - required.
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Procures technical information from QA/QC databases for the NOW sales teams for regulatory and registration requests. Associate’s degree from a two year post high school college or bachelor's degree (BA or BS) from four-year college or university with a related degree in biology, chemistry, nutrition and/or quality/regulatory compliance with 4 years of experience collaborating with a government regulatory agency preferred.
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Experience in Food Regulatory Affairs relating to confectionery or salty snacks preferred but not required. Assist team in creation and collection of documents needed to fulfill customer requests for nutrition and other regulatory materials.
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The Principal Regulatory Affairs Operations Specialist will report to the Regulatory Affairs (RA) Operations Manager and be responsible for assuming the regulatory functional owner role of the Philips data management solution (Rimsys), providing testing support for upgrades and releases of Philips tools, tracking and reporting global regulatory submissions and licensing data, and identifying and resolving issues related to regulatory master data.
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This is a mid-level regulatory affairs position that requires the ability to integrate regulatory knowledge throughout the product lifecycle with effective project coordination. 2-5 years in a medical device organization, preferably in regulatory affairs.
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The Regulatory Affairs Specialist will support the development of submissions for domestic and international clearances for spine surgery products; as well as the support of daily activities related to product design teams, change control, and regulatory product submissions.
$92,600 - $112,700Full-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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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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We are seeking a Principal Regulatory Affairs Specialist to join Abbott's Heart Failure Division on-site in Pleasanton, CA. As an experienced individual contributor, a Principal Regulatory Affairs Specialist is to provide support for the regulatory department, ensuring efficient and compliant business processes and environment.
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Minimum of 3 years combined work experience in heavily regulated fields such as medical devices, pharmaceuticals, or biologics, with a minimum of 2 years’ experience in Regulatory Affairs.
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Regulatory Affairs Specialist 1 needed for a one year W2 contract for a Bio Manufacturing Company in Hercules, CA. Interface daily with desktop publisher, technical writers and Regulatory Affairs Specialists.
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regulatory affairs jobs Title: regulatory affairs specialist
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