• Beckman Coulter Diagnostics (Miami, FL)
    …regulations and standards including compliance with Food & Drug Administration (FDA), Medical Device Single Audit Program (MDSAP), ISO13485, European Union ... Medical Device Directives (MDD), and In-Vitro Medical ...not required but training and certificates in quality or regulatory affairs would be a plus (eg… more
    JobGet (05/01/25)
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  • Regulatory Affairs Program Manager…

    Olympus Corporation of the Americas (Westborough, MA)
    …preferred, BS or comparable required + Minimum of 5-7 years experience in Regulatory Affairs in Medical Device Industry with focus on Software driven ... / Machine Learning-enabled medical devices + Expert in Regulatory Affairs for Software as a Medical Device and Class I/II/III medical devices.… more
    Olympus Corporation of the Americas (04/23/25)
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  • Associate Manager, Regulatory

    Stryker (Portage, MI)
    …Premarket Approval devices is highly desirable + Familiarity with European medical device regulations + Regulatory Affairs experience within Medical ... Stryker is hiring an **Associate Manager, Regulatory Affairs ** preferrable in **Portage, MI,**...Device preferred + Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and international requirements +… more
    Stryker (05/06/25)
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  • Sr. Regulatory Affairs Specialist

    Caldera Medical (Westlake Village, CA)
    …Sciences, Biomedical Engineering, or a related field. * 5-7 years of regulatory affairs experience in the medical device industry. * Strong understanding ... Regulatory specialist, you will develop and implement medical device regulatory strategies to...Excel, Office, PowerPoint, and Adobe). * Regulatory Affairs Certification (RAC). Who is Caldera Medical ?… more
    Caldera Medical (03/27/25)
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  • Staff Regulatory Affairs Specialist…

    BD (Becton, Dickinson and Company) (San Diego, CA)
    …is preferred. **Experience** * Minimum of five (5) years of Regulatory Affairs experience in the medical device and/or pharmaceutical industry. ... of possible** with us. **Job Overview** As a Staff Regulatory Affairs Specialist in Advertising/Labeling, you will...existing US and international regulations and directives (eg, FDA Medical Device Regulations, EU Low Voltage Directive,… more
    BD (Becton, Dickinson and Company) (04/17/25)
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  • Regulatory Affairs Program Manager

    Olympus Corporation of the Americas (Westborough, MA)
    …and future approvals to management. **Job Qualifications** **Required:** + Regulatory affairs experience in the Medical Device industry is mandatory ... (https://www.olympusamerica.com/careers) . **Job Description** Assist the Manager, Regulatory Affairs in obtaining approval to market Olympus medical devices… more
    Olympus Corporation of the Americas (02/19/25)
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  • Manager, Regulatory Affairs (IVD)

    Hologic (San Diego, CA)
    …direct experience in Regulatory Affairs within the IVD or medical device industries. + Master's Degree in biomedical engineering and/or RAC preferred ... of 5-8 years direct experience in Regulatory Affairs within the IVD or medical ...Regulatory Affairs within the IVD or medical device industries. + Software/instrumentation experience strongly… more
    Hologic (04/09/25)
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  • Sr Regulatory Affairs Specialist

    Imperative Care (Campbell, CA)
    …of education/training and experience. + An advanced degree or regulatory affairs experience in the medical device industry strongly preferred. ... Title: Sr Regulatory Affairs Specialist This position is...of experience in related roles at healthcare, pharma, or medical device industries; or an equivalent combination… more
    Imperative Care (03/28/25)
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  • Assistant/Associate Professor (Lecturer) for…

    University of Utah (Salt Lake City, UT)
    …a 9-month (annually Aug. 16 - May 15) Career-line faculty position in the area of Regulatory Affairs , Medical Device Design and Regulatory Science. ... and strong interest in teaching Regulatory Affairs , Regulatory Science, and medical device design courses. Practical experience in regulatory more
    University of Utah (03/19/25)
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  • Regulatory Specialist

    Globus Medical, Inc. (Audubon, PA)
    …Engineering degree is a plus + Minimum of 2-5 years' experience in Regulatory Affairs in the medical device industry, , preferably within orthopedic ... their lives as quickly as possible. **Position Summary:** The Regulatory Affairs Specialist assists with drafting, submitting...medical devices; + Experience in medical device development and registration of products… more
    Globus Medical, Inc. (04/11/25)
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