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Assists with regulatory submissions to the Institutional Review Board (IRB) including submission of Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines.
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International product registration, Regulatory affairs, Labeling review, Medical device, Regulatory, Labelling, Regulatory submission, product claims review, 510k, FDA QSR, Technical files, tissue bank registration, implantable device.
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The FRM will need to coordinate cross functionally within Field Sales, Marketing, Market Access, Public Affairs, State & Government Affairs, Trade, and Specialty Pharmacy Account Management.
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This person must comply with current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), Laboratory Safety and any regulatory requirements. Lief Labs is a premier formulation and product development innovator and manufacturer of dietary supplements.
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This position is based in Six Flags Magic Mountain!
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With more than 120 operations and approximately 20,000 employees worldwide, Precision Castparts Corp. is the market leader in manufacturing large, complex structural investment castings, airfoil castings, forged components, aerostructures and highly engineered, critical fasteners for aerospace applications.
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Inverter- Sr Electronic Engineer. 10 years of MATLAB/Simulink and PCB layouts including design and validation of circuit board experience. PCB layout with Altium or similar. 5-7 years of experience with power electronics and PCB design in high end motorsport i.
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Weekend availability cannot fall on the same day; an associate must be available on two separate days (Friday and Saturday, Friday and Sunday or Saturday and Sunday). For an associate to be scheduled 20 hours or more weekly, greater availability (beyond the minimum required above) that meets the needs of the business will be required.
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Regulatory Affairs Specialist II – Neuromodulation. RA certification (by Regulatory Affairs Professional Society) A minimum of a bachelor’s degree and 1-3 years’ work experience in regulatory affairs or a masters in regulatory sciences.
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Interaction with the NA salesforce, customer service, global marketing, legal, offer development and pricing, R&D, regulatory, marketing communications, quality, logistics, and various customers such as surgeons, Audiologists, and hospital administration.
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Handle/manage all duties related to the execution of US/OUS Class 3 Medical Device Clinical Trials in line with GCP, Regulatory and Compliance requirements. This position plays a key role in the development and execution of pre-clinical, feasibility and first-in human trials intended to support regulatory registration of new indications and new medical devices, as well as physician-initiated and company sponsored, and grant funded clinical trials.
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Under the supervision of a Laboratory Supervisor, the Clinical Lab Scientist is responsible for specimen processing, test performance test result reporting, clerical and patient care support services with a high level of accuracy, precision and timeliness while ensuring compliance with departmental and regulatory agency standards.
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Under the guidance of the Executive Director, Advancement Services, the Associate Director, Database Administration, manages Advancement’s Salesforce CRM along with CalArts’ event management and online giving platforms.
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As a Mobile Associate, you will be required to successfully complete new employee training. Within the first 90 days working at T-Mobile, Mobile Associates will receive on-the-job training and the opportunity to earn a total of $1,500 while completing training milestones.
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Merchandising Sales Associate. fot full-time and eligible part-time TSC and Petsense Team Members. Farming, ranching, pet/equine, or welding knowledge is strongly preferred. Your Opportunity is Out Here at Tractor Supply and Petsense.
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regulatory affairs jobs Title: sr regulatory associate Company: Cardinal Health in Santa Clarita, CA
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