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Prepare and submit product registrations and submissions (510(k), PMA) to FDA and other regulatory bodies. Glidewell Laboratories is the industry leader in dental technology due to our agility, speed, and cutting edge technology.
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Directs contribution to all device history, risk mitigation, and quality documents for the devices required for regulatory filings (i.e., 510k, De Novo 510K and PMA). Experience in computational fluid dynamics and FEA simulation.
ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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As a key member of our Drug Delivery Programs team, the successful Senior Product Development Engineer is responsible for providing mechanical design engineering technical leadership on cross-functional product development teams during the pre-concept, development, design, test and documentation for manufacture of new and improved disposable medical and surgical devices, instruments or related products.
Full-timeExpandApply NowActive JobUpdated 24 days ago - UpvoteDownvoteShare Job
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Plans and prepares (or oversees) complex regulatory documents for US (PMA, IDE, IDE supplements and annual reports, FDA meetings) and potentially OUS submissions, under minimal supervision. At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products.
Full-timeExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
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Plans and prepares complex regulatory documents for US (PMA, IDE, IDE supplements and annual reports, FDA meetings) and potentially OUS submissions, under supervision. Plans and prepares complex regulatory documents for US (PMA, IDE, IDE supplements and annual reports, FDA meetings) and potentially OUS submissions, under supervision.
Full-timeExpandApply NowActive JobUpdated 20 days ago - UpvoteDownvoteShare Job
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Works collaboratively with PMA nurse professionals to develop and execute return to work strategies. Authorizes treatment based on the practiced protocols established by statute or the PMA Managed Care department.
$66,200 - $80,900 a yearFull-timeRemoteExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
Full-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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Work with R&D Engineers to provide design and development documents to the Regulatory department for preparing the PMA, 510(k), special 510(k), and/or European submission files. Proficient computer skills including MS Word, Excel, Teams, Outlook, and statistical software (e.g., MiniTab, Design of Experiment DOE, etc.
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10-15 years of specific and direct experience in Regulator AffairsDemonstrated success approvals of US FDA, European MDR, and Australian Regulatory marketing approvals for Medical Devices including 510(k), PMA, CE Mark for multiple device classificationsImpeccable verbal and written communication skills.
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Minimum 5 years of US Medical Device (PMA, 510k) /Pharmaceutical/ Biologics/ Medical Products/ experience in a marketing role. Manages marketing plans by working collaboratively with Sales, Sales Training, Medical Affairs, Professional Relations, Market Access/Reimbursement, Operations, Supply Chain, Legal, Compliance, Finance and Regulatory Affairs.
ExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Participate in and drive IDE data analysis and drive PMA CSRs, sub analyses. Have extensive knowledge of clinical and preclinical data in our space and build materials with the goal of achieving market access and adoption.
ExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports). Regulatory Affairs Associate , working in. Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports.
ExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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Experience and proven ability in preparing US regulatory submissions e.g., IDE, 510(k), PMA, and technical documentation. Proven knowledge of regulatory requirements and experience preparing international documents, such as STEDs, Design Dossier, and Technical Files and new products registration for Non-EU, Canada, LATAM, APAC (Australia, New Zealand, Korea, Taiwan, and Singapore), and EMEA.
ExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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Description Position at Prismatik Essential Functions:Prepare and submit product registrations and submissions (510(k), PMA) to FDA and other regulatory bodies. Glidewell Laboratories is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment.
ExpandApply NowActive JobUpdated 5 days ago
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