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This Senior Regulatory Affairs Specialist will have an opportunity to work on new to market technology that is improving the field of diagnostic imaging and saving patient lives. Senior Regulatory Affairs Specialist-Remote Based-West Coast.
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The CS may have contact with internal colleagues in pharmaceuticals, marketing, sales, research and development, strategy and portfolio management, regulatory, technical services, and medical affairs team members.
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FDA Annual Reports responsibilities: " Provide all LIMS stability reports to Regulatory Affairs for inclusion in the FDA Annual Reports in accordance with the predefined schedule." The Principal QA Specialist role is a temporary role within the US Commercial Quality organization.
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OR BS degree in health-related or scientific field with 7-10 years of experience in pharmaceutical industry, directly related clinical trial experience or experience in areas relevant to drug discovery or development, e.g. epidemiology, toxicology, pharmacovigilance, regulatory affairs.
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Support for regulatory publishing including assembling, printing, quality checking, archiving of regulatory submissions and corresponding data. Plan, prepare and review all aspects of ongoing and new regulatory submissions, both U.S. (e.g., PMA, IDE, 510(k), PMA Annual Reports, etc.
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Regulatory Affairs Manager. Provide backup for other staff on the Regulatory Affairs Team. Core areas of focus include assisting staff in writing quality and compliant polices, serving as administrator for PolicyTech software, monitoring to ensure policies are current, developing efficient processes, training staff on best practices, and tracking regulatory requirements.
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As the Staff Regulatory Affairs Specialist, you will engage in technical and scientific regulatory activities to include project management, writing, coordination, and execution of regulatory documentation for new product development.
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About the Role:Job SummaryThe Research Regulatory Specialist performs a wide range of tasks essential to the submission, approval, and maintenance of required regulatory documents for conducting clinical research in compliance with the Federal Food and Drug Administration (FDA.
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The Complaint Specialist works with a team of Quality, Clinical and Regulatory Affairs professionals to provide hands-on complaints handling and ensure customer complaints are reviewed and processed in a timely manner.
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The Regulatory Specialist is responsible for product compliance, design consultation, testing, and submission activities for ensuring global regulatory compliance. STEM-related Bachelor's degree with 3+ years of experience in product compliance, quality, or regulatory affairs, OR STEM-related advanced degree with 2+ years of experience in product compliance, quality, or regulatory affairs.
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Interact directly with the FDA and/or indirectly with international regulatory agencies on most products/projects at reviewer level; all significant issues will be reviewed with management. Determines and documents global regulatory pathways for various projects including product classification and type of regulatory submission or rationale required for new products and changes to existing products.
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Supports regulatory compliance activities, including manufacturing site registration, Notified Body audit, product recalls, etc., as needed. Prepares, delivers and defends regulatory submissions to the FDA, the Notified Body and other regulatory authorities and/or distributors.
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The Sr. Regulatory Affairs Specialist is responsible for providing advanced level regulatory input for regulatory documentation and development or sustaining projects to ensure that regulatory requirements are met.
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The Senior Regulatory Affairs Specialist serves as the liaison to clients and internal functional departments for all matters regulatory and compliance related. We're hiring for a Senior Regulatory Affairs Specialist to support compliance and regulatory affairs in Bloomington, Indiana.
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The Regulatory Specialist will be responsible for a wide range of duties related to regulatory compliance, data analysis, stakeholder collaboration, system management, and program implementation in the healthcare setting.
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