• Senior Counsel ( Medical Device )

    Fujifilm (Sacramento, CA)
    …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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  • 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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  • Senior Manager Regulatory Affairs - Global…

    Abbott (Santa Clara, CA)
    …providing strategic and predictable Regulatory Services in collaboration with the medical device business units that Leveraged Services team supports. **The ... on regulatory activities and works with the medical device business units that Leverage Services...and leadership experience to support the medical device business units with their regulatory submissions.… more
    Abbott (08/08/25)
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  • Medical Device Program Manager

    US Tech Solutions (San Bruno, CA)
    …of Quality Concepts (eg, Statistical Analysis, NC/CAPA, Audits) and US and International Medical Device Regulations & Regulatory Agencies (eg, FDA, Notified ... + Managing cross-functional or cross-team projects to bring regulated medical device products to market. + Ensuring...and mentoring to engineers to ensure audit readiness and regulatory submissions. + Support bringing novel medical more
    US Tech Solutions (07/18/25)
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  • Regulatory Affairs Manager, Diagnostics/IVD

    Kelly Services (Oakland, CA)
    …related experience, or PhD + 5 years of related experience . 6-8 years of regulatory experience in a medical device and/or diagnostics company involved with ... **Kelly(R) Science & Clinical** is seeking a Sr. Regulatory Affairs Manager for a contract-to-hire position at a cutting-edge client in Seattle, WA . If you're… more
    Kelly Services (08/08/25)
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  • Senior Manager, Quality - Combination Products,…

    Gilead Sciences, Inc. (La Verne, CA)
    … reports (MDRs) and provide documented justifications for reportable and non‑reportable regulatory decisions. + Support medical device and combination ... provides comprehensive support of these combination products. **Roles/Responsibilities:** + Monitor medical device standards for quality management system (QMS)… more
    Gilead Sciences, Inc. (07/08/25)
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  • Regulatory Affairs Specialist II - Ventures…

    Abbott (Santa Clara, CA)
    …in a broader enterprise/cross-division business unit model. + Experience working in the Medical Device industry. + Regulatory Affairs Professionals Society ... to various international affiliates. + Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are… more
    Abbott (08/16/25)
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  • Regulatory Affairs Associate Director, IVD

    GRAIL (Menlo Park, CA)
    …clinical affairs, quality, or program management within the IVD, medical device , or pharmaceutical industries. + Regulatory affairs and IVD device ... US and international regulatory frameworks and processes for medical device development and approvals. + Effective collaborator in dynamic, fast-paced, and… more
    GRAIL (08/16/25)
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  • Labeling Specialist (Med Device )

    Actalent (San Diego, CA)
    …of new and revised labeling materials. Required Skills & Experience: + Experience in medical device labeling and regulatory compliance. + Proficiency in ... the labeling process for both new and existing In Vitro Diagnostic (IVD) and Medical Device (MD) products. This role requires cross-functional coordination and a… more
    Actalent (08/23/25)
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  • Staff Regulatory Affairs Specialist

    BD (Becton, Dickinson and Company) (San Diego, CA)
    …of five (5) years of Regulatory Affairs experience in the medical device industry required + Strong prioritizing, interpersonal, communication, and ... of possible** with us. **Job Overview** As a Staff Regulatory Affairs Specialist, you will play a crucial role...existing US and international regulations and directives (eg, FDA Medical Device Regulations, EU Low Voltage Directive,… more
    BD (Becton, Dickinson and Company) (07/11/25)
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