• Manager, Regulatory Affairs Medical…

    Bausch Health (Bothell, WA)
    …Bachelors Degree Required Life science or technical discipline preferred. Minimum 6 years regulatory experiences in MNC medical device company (aesthetic ... device is a plus). Demonstrates profound knowledge and expertise in Active Medical Device international regulations, focus on US/Canada/MDR and APAC is a… more
    Bausch Health (07/09/25)
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  • Regulatory Affairs Specialist II,…

    ThermoFisher Scientific (Pittsburgh, PA)
    …5 years of proven experience in regulatory affairs, ideally within the medical device or pharmaceutical industry. + Strong understanding of FDA regulations, ... Boards of Pharmacy (NABP) regulations. + Organize and validate device data for submission and registration with the FDA...as well as state and international regulations related to medical devices. + Demonstrate ability to maintain regulatory… more
    ThermoFisher Scientific (08/13/25)
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  • Manager, Regulatory Affairs- Medical…

    Bausch Health (Bothell, WA)
    … required + Must have a solid understanding of Change Management/Life Cycle Management of medical device products along with the impact of changes on US Canada ... written and communication skills. + Should have experience authoring complete 510(k) submissions, Medical Device license applications (Class II or above), EU MDR… more
    Bausch Health (07/10/25)
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  • Senior Counsel ( Medical Device )

    Fujifilm (Honolulu, HI)
    …to Division General Counsel and senior business management on general legal and regulatory risks affecting the Medical Device businesses, including with ... part of the legal team providing support to the Medical Device businesses of FUJIFILM Healthcare Americas...other applicable laws. + Keep abreast of legislative and regulatory changes with respect to healthcare and other relevant… more
    Fujifilm (08/08/25)
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  • GRA Device Lead (Director)

    Sanofi Group (Morristown, NJ)
    …(early phase, late stage and marketed products). + Develop innovative and sustainable medical device regulatory strategies covering combination products and ... with 10 years regulatory experience. At least 5 years of relevant medical device and/or combination product regulatory experience required. + At least 10… more
    Sanofi Group (07/15/25)
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  • Quality Systems & Compliance Lead…

    Jabil (West Chester, PA)
    …and foster vibrant and diverse communities around the globe. Are you experienced in Medical Device Regulatory Compliance? Jabil is seeking a qualified ... Quality Systems & Compliance Lead for Medical Device to work in our West..., you will manage, as an individual contributor, all Regulatory Compliance activities at the assigned sites. You will… more
    Jabil (08/29/25)
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  • Director, Global Regulatory Affairs

    Candela Corporation (Marlborough, MA)
    …RA topics required for both tactical and strategic initiatives. + Possess and exercise regulatory and medical device industry relationships to inform bold RA ... **Director, Global Regulatory Affairs** Requisition Number **2872** Location **US -...sciences/engineering/related field, plus 12 years of experience in the medical device industry with at least 10… more
    Candela Corporation (08/29/25)
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  • Sr. Regulatory Affairs Specialist

    Caldera Medical (Westlake Village, CA)
    …your role as a Sr. Regulatory specialist, you will develop and implement medical device regulatory strategies to obtain timely approvals from worldwide ... provide regulatory input and guidance to cross-functional partners regulatory documentation for medical device approvals in compliance with EU MDR,… more
    Caldera Medical (08/24/25)
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  • Regulatory Affairs Specialist

    BioFire Diagnostics, LLC. (Salt Lake City, UT)
    …Bachelor's Degree required. Science background is preferred. Specialist: 3+ years in regulatory affairs, medical device /IVD industry required. 3+ years ... The Regulatory Affairs position within Regulatory Policy & Intelligence (RP&I) is responsible for contributing to or leading impact assessments and for changes… more
    BioFire Diagnostics, LLC. (07/23/25)
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  • Regulatory Affairs Specialist

    BioFire Diagnostics, LLC. (Salt Lake City, UT)
    …and Experience: Bachelor's Degree. Science background is preferred. 3+ years in regulatory affairs required, medical device /IVD industry preferred. ... A member of the RA team responsible for developing regulatory strategy and assessing regulatory risks for...worldwide approval. They may also perform and/or assist with medical device reporting or field actions. This… more
    BioFire Diagnostics, LLC. (08/02/25)
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