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Familiarity with US FDA regulations, i.e. 501(k), IDE, PMA. Principal Mechanical Engineer. Our projects range from telemedicine and diagnostic platforms to wearables, drug delivery devices, and surgical systems.
ExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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PMA is currently seeking a multidiscipline Program Manager and Project Controls Engineer for an exclusive assignment for one of our largest and longest-running clients. If you aim to transform the project management practice toward continuous improvement of project outcomes, the profession, and yourself, PMA looks forward to warmly welcoming you to our team.
Full-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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PMA is currently seeking a Project Management System Administrator for an exclusive assignment for one of our largest and longest-running clients. As a PMA professional, you will be empowered to make timely and effective decisions and significant daily contributions to complex facets of project delivery.
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Specific experience in US IDE, 510(k), De Novo, and/or PMA submissions, EUMDR and global regulatory approvals is critical to the success of this position. Strategic Sourcing Director-IT. Specific experience in US IDE, 510(k), De Novo, and/or PMA submissions, EUMDR and global regulatory approvals is critical to the success of this position.
ExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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PMA is comprised of over 150 project professionals experienced and licensed in nearly every aspect of the real estate industry with multi-disciplined backgrounds that are heavily rooted in the built environment, including architecture, development, asset management, brokerage, construction, engineering, finance, and urban planning.
$130,000 - $180,000 a yearFull-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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Participate in or lead interactions with global regulatory authorities, including authoring briefing documents, attending in person meetings, and contributing to IND, CTA, IDE, expedited pathway, 510(k), PMA, NDA, and/or MAA filings.
ExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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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.
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Major contributions to or the leadership of projects from development through the 510k and PMA approval process. Review and approve quality records (deviations, CAPA/EVs, change controls) The Quality Assurance Manager will also provide Quality oversight of quality records such as Deviations, CAPAs, Change controls and review/approval of physical test methods documents.
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Supporting Class III IDE and PMA submissions. Support Class III IDE and PMA submissions. Supporting Class III IDE and PMA submissions. Support Class III IDE and PMA submissions. Location: Greater Boston, MA – need candidates that area in MA, ME, or NH.
Full-timeExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
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Collaborate with internal teams and diagnostic partners to align on co-development regulatory needs and expectations, including regulatory submissions (e.g., PMA, 510(k), IDE). The primary focus of this position will be on ensuring Good Laboratory Practice (GLP) and ISO conversion for a team dedicated to assisting cancer patients using various molecular techniques, including MXIF, IHC, Flow cytometry, and DNA and RNA sequencing (exome.
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Familiarity with FDA complaint handling procedures during an IDA and post PMA. BrioHealth Solutions Inc., Inc. is an advanced medical device company dedicated to the research, development, and commercialization of a miniaturized implantable ventricular assist system (CH-VAD ® ) featuring total magnetic suspension (TMS) for the treatment of end-stage chronic heart failure.
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Pre-market applications (510(k), de novo, PMA) Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways.
Full-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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In this role, you will be involved in every stage of in the software development lifecycle, from requirements definition to post-market surveillance. BrioHealth Solutions Inc., Inc. is seeking a Software Quality Engineer to support design quality efforts for an active implantable medical device, covering both clinical and commercial needs in a GMP environment.
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