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Author PMA or 510(k) submissions to include PMA and PMA supplements for US Class II and Class III medical devices. Leading and authoring PMA or 510(k) submissions to include PMA and PMA supplements for US Class II and Class III medical devices.
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Senza®, Senza II®, and Senza Omnia™ are the only SCS systems that deliver Nevro's proprietary 10 kHz Therapy. Senior Regulatory Affairs Specialist, Redwood City, CA - Develop strategies for global approvals to introduce new Spinal cord stimulation systems to market, maintain existing products, provide advice on regulatory requirements, prepare worldwide submissions, and negotiate approval with global regulatory agencies.
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As a Housekeeping Houseperson PMA, you would be responsible for maintenance of guest rooms and public areas, assist room attendants with general cleaning or guest rooms, assist with distributing & collecting linens, and respond to guest requests in the hotel's continuing effort to deliver outstanding guest service and financial profitability.
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Experience with Medical Device-IVD, 510K/PMA and/or lab-developed test diagnostic clinical trials, preferred. Karius is revolutionizing the diagnosis and management of infectious diseases through multiple innovations including microbial cell-free DNA signal processing, metagenomic sequencing, and bioinformatics including use of advanced machine learning and artificial intelligence.
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Minimum of 10 years of progressive quality assurance experience in the medical device, electrosurgical industries (Class II, Class III, or PMA). Element Science, Inc. is a medical device and digital health company focused on developing solutions at the intersection of clinical-grade wearables, machine learning algorithms, and lifesaving therapies in order to address leading causes of death and hospitalization in patients with heart disease, primarily as they transition from the hospital-to-home.
$215,000 - $500,000 a yearTemporaryExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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The Sr. Scientist will plan, execute, implement, and document all design transfer activities for an IVD/PMA assay under design control, for next generation sequencing (NGS) assays. Significant role in PMA submission, audit prep and qualification of suppliers and manufacturing processes.
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Experience with 510(k) or PMA submissions. As a health-tech company, we place great worth on our team’s well-being. We support what you need to be your best self when at work! Lead product risk management, including hazard identification, risk evaluation, and risk control within product teams.
$120,000 - $150,000 a yearFull-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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The Senior Quality Engineer will play a key role in the design, development, and production of high quality and compliant medical devices at identifeye, as well as the maintenance and improvement of an effective Quality Management System.
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What You Will Be Doing The Senior Quality Engineer will play a key role in the design, development, and production of high quality and compliant medical devices at identifeye, as well as the maintenance and improvement of an effective Quality Management System.
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Responsible for compilation of Class III medical device Regulatory submissions (IDE/supplements, PMA/supplements, Design Dossier, and any required international submissions. Experience with FDA IDE, PMA and Australia submissions.
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