• Digital Device Quality Expert - SaMD

    Sanofi Group (Cambridge, MA)
    …Tree Analysis (FTA), Failure Modes and Effects Analysis (FMEA) + Good knowledge of medical device regulations and international standards, eg: ISO 13485, 21 ... more
    Sanofi Group (03/09/25)
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  • Medical Device Program Manager

    US Tech Solutions (San Bruno, CA)
    …knowledge of Quality Concepts (eg, Statistical Analysis, NC/CAPA, Audits) and US and International Medical Device Regulations & Regulatory Agencies (eg, FDA, ... more
    US Tech Solutions (01/17/25)
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  • Regulatory Affairs Manager - International

    Abbott (Alameda, CA)
    …+ Advanced level degree + Experience with FDA, ANVISA, TGA, NMPA, EU and other international medical device / drugs / pharma regulations and submissions. + ... more
    Abbott (03/22/25)
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  • Future Opportunities - Join Our Talent Pipeline…

    AbbVie (Irvine, CA)
    …with FDA's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which ... more
    AbbVie (03/20/25)
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  • Future Opportunities - Join Our Talent Pipeline…

    AbbVie (Pleasanton, CA)
    …with FDA's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which ... more
    AbbVie (03/20/25)
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  • Principal, Clinical Evaluation Specialist…

    J&J Family of Companies (Santa Clara, CA)
    …a PMA/PMAs (US Class III), IDE (US Class II/III), 510K (US Class III), other international medical device applications or other technical writing needs as ... more
    J&J Family of Companies (03/06/25)
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  • Quality Engineer I

    Olympus Corporation of the Americas (Center Valley, PA)
    …98/282 Canadian Medical Device Regulations, ISO 13485, and any other medical device industry international standards a plus. + Formal education ... more
    Olympus Corporation of the Americas (01/30/25)
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  • Internal Audit Manager

    Terumo Medical Corporation (Somerset, NJ)
    …and conducting audits in operations, systems and other areas pertinent to the medical device industry preferred + International exposure most desirable ... more
    Terumo Medical Corporation (02/11/25)
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  • Senior Regulatory Affairs Specialist (on-site)

    Abbott (Plymouth, MN)
    …+ Maintains ongoing surveillance and analysis of all pertinent domestic and international medical device regulations to ensure submission requirements ... more
    Abbott (02/17/25)
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  • Senior Regulatory Affairs Specialist…

    Abbott (Plymouth, MN)
    …+ Maintains ongoing surveillance and analysis of all pertinent domestic and international medical device regulations to ensure submission requirements ... more
    Abbott (03/13/25)
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  • Senior Regulatory Affairs Specialist - Cardiac…

    Abbott (Sylmar, CA)
    …+ Maintains ongoing surveillance and analysis of all pertinent domestic and international medical device regulations to ensure submission requirements ... more
    Abbott (02/04/25)
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  • Director Of Quality

    Globus Medical, Inc. (Limerick, PA)
    …and procedures. Lead and enforce regulatory compliance with US FDA, State, OSHA and international medical device regulations and ISO 13485 quality system ... more
    Globus Medical, Inc. (02/14/25)
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  • Regulatory Affairs Specialist II…

    Abbott (Plymouth, MN)
    …to various international affiliates. + Maintains pertinent domestic and international medical device regulations to ensure submission requirements ... more
    Abbott (01/11/25)
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  • RA Fellow Devices

    Fresenius Medical Center (Waltham, MA)
    …of the development and change processes. + Understands and interprets US and international medical device regulatory requirements; provides guidance on ... more
    Fresenius Medical Center (03/14/25)
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  • Principal RA Associate Devices

    Fresenius Medical Center (Raleigh, NC)
    …critical issues and broad design matters. + Understands and interprets US and international medical device regulatory requirements, provides guidance on ... more
    Fresenius Medical Center (03/05/25)
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  • Diagnostic Regulatory Affairs Manager

    Amgen (Washington, DC)
    …+ 6 plus years of experience in Regulatory Affairs, including United States and international medical device and/or IVD/CDx regulations + 8 plus years ... more
    Amgen (03/21/25)
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  • Surgical Robotics and Imaging Field Service…

    Globus Medical, Inc. (UT)
    …with all company policies & procedures and maintaining compliance with US FDA and international medical device regulations and ISO 13485 quality system ... more
    Globus Medical, Inc. (03/13/25)
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  • Senior Specialist - Regulatory Affairs

    Integra LifeSciences (Braintree, MA)
    …teams, marketing teams, quality teams). + Strong working knowledge of domestic and/or international medical device regulations including 510k, PMA, PMA ... more
    Integra LifeSciences (03/06/25)
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  • Principal Regulatory Affairs Specialist - Heart…

    Abbott (Pleasanton, CA)
    …PMA supplements and US device regulations, or with EU and other international medical device regulations and submissions. + Must be familiar ... more
    Abbott (03/04/25)
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  • Regulatory Affairs Manager - Heart Failure…

    Abbott (Pleasanton, CA)
    …PMA supplements and US device regulations and/or experience with EU and other international medical device regulations and submissions. + Ability to work ... more
    Abbott (03/17/25)
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