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Experience in Device Quality System, Design, Manufacturing and Testing, 21 CFR Part 820, DHF, DHR, DMR, and overall Device Regulations, CDRH and 510 k or PMA approvals are a plus. Monitor, track, and trend stability data and GMP quality systems and establish metrics.
ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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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 2 months ago - UpvoteDownvoteShare Job
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Prepares and submits Pre-subs/ PMA/ IDE Submissions and supplements for new products and product changes as required to ensure timely approvals for clinical studies and market release. Minimum of 7 years of regulatory experience within the medical device cardiovascular industry preparing Pre-submissions, PMA submissions is required.
ExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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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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Experience working with Class III medical devices (PMA, IDE, EU MDR) Must demonstrate a history of successful Class III device submissions such as IDEs, PMAs, PMA supplements, 30-day notices, and Annual Reports in the US.
$120,691 - $150,864 a yearFull-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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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.
$195,000 - $210,000 a yearFull-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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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.
$20.75 an hourExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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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.
ExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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We have acquired two FDA approved non-opioid pain products, GLOPERBA and ELYXYBTM, for the treatment of gout in adults and oral solution for the acute treatment of migraine, with or without aura, in adults.
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PMA submission expertise is required. The Principal Regulatory Affairs Specialist will be an individual contributor that will bring exceptional technical regulatory expertise. Minimum of a Bachelors’ degree preferably in life sciences and/or biomedical engineering.
ExpandApply NowActive JobUpdated 9 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.
ExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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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.
ExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Working knowledge of the FDA submission process including IDE, PMA, and 510(k). The Senior Clinical Research Associate I (CLRA) is responsible for site management deliverables on assigned protocols and may act as a lead CRA for the study, providing guidance and support to other CRAs on the team.
ExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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The Staff/Principal Regulatory Affairs Specialist will be part of a high-performing RA team and responsible for contributing to the development of regulatory strategies, preparing U.S. and major market submissions and obtaining approval for the ReCor Medical product portfolio.
Full-timeExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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Commercial Complaint Processing with MDR/Vigilance experience is required. By putting the needs of patients and physicians first, our personalized digital devices, which are designed for function, comfort, and ease-of-use, aim to redefine the paradigm of care for these patients.
ExpandApply NowActive JobUpdated 6 days ago
pma job in Redwood City, CA
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