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Hands-on experience with 510k submissions, or PMA/s or US Annual report or CE Technical documentation preparation. Job Summary: We are seeking a regulatory affairs specialist to assist and lead in the definition/implementation of regulatory strategy and priorities in conjunction with management, peers, and commercial, and affiliate personnel in the medical device industry.
$98,000 - $108,000 a yearExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Manage the preparation and submission of regulatory filings, including 510(k) premarket notifications and PMA applications, ensuring compliance with FDA requirements. Title: Regulatory Affairs Manager.
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Previous experience with PMA / IDE and international submissions. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Recent experience with Class III implantable medical devices; Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements; knowledge of FDA PMA guidance documents and CFR regulations.
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Work closely with the PMA analog design team. Develop system Verilog/UVM Mix signal test benches, test plans, SV checkers for the verification of RTL and analog functions. Experience in CMOS circuit design or Mixed signal design verification.
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Work collaboratively with PMA nurse professionals to develop and execute return to work strategies. Authorize treatment based on the practiced protocols established by statute or the PMA Managed Care department.
$66,200 - $80,900 a yearFull-timeExpandApply NowActive JobUpdated 15 days ago - UpvoteDownvoteShare Job
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Familiarity with wireless charging standards such as Qi (WPC) or PMA. Your dedication to cross-disciplinary collaboration will help develop groundbreaking technologies, such as iOS, macOS, watchOS, and tvOS. By crafting these distinct, holistic user experiences, you'll continue to uphold and advance the excellence people expect from Apple devices.
$138,900 - $256,500 a yearExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Authoring experience in FDA product submissions (IDE, PMA, 510k) The Principal Regulatory Affairs Specialist hired will report to the Senior Director of Regulatory and Quality, with sights to build out an RA team as needed.
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Experience with either 510(k) applications, PMA supplements and US device regulations or with EU and other international medical device regulations and submissions. This Regulatory Affairs Specialist will work out of our Temecula or Santa Clara, CA location in the Vascular Division.
$65,900 - $131,900 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago
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