• 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 ... in multiple ex-US jurisdictions, including the EU, APAC, Australia, and assume regulatory responsibility for compliance with IVDR. . Develops and executes… more
    Kelly Services (08/08/25)
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  • Director, Regulatory Affairs - Job ID:

    Ascendis Pharma (Palo Alto, CA)
    …drug- device combination products preferred. + Experience in filing regulatory dossiers including CTAs, IMPDs, INDs required; experience with marketing ... mission of developing new and potentially best-in-class therapies to address unmet medical needs. Our culture fosters a place where skilled, adaptable, and highly… more
    Ascendis Pharma (06/07/25)
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  • Senior Regulatory Labeling Specialist…

    Medtronic (Irvine, CA)
    …degree in science, communication, or a healthcare-related field + 4 years of medical device experience, including knowledge of the US and International ... and author new process documents + Monitor changes and compliance with applicable FDA and international regulatory ...years' experience **Nice to Have:** + US and International medical device industry experience in Advertising &… more
    Medtronic (08/28/25)
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  • Senior Project Manager, International…

    Stryker (San Jose, CA)
    …a related field + 6+ years of experience in a regulated environment ( Medical Device , Pharmaceutical, Biomedical, or Automotive). + Experience leading and ... **Senior Project Manager, International Regulatory Affairs** _San Jose, CA / Flower Mound,... teams, and global partners to drive alignment, ensure compliance , and deliver high-impact results. **What you will do:**… more
    Stryker (08/29/25)
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  • Head of Quality & Compliance , Monarch…

    J&J Family of Companies (Santa Clara, CA)
    …Director or above in a quality function across Design and Development including End-to-End Quality & Compliance in Medical Device . + Must have a minimum of 5 ... regulated industry with at least 12 years in a medical device industry. + A minimum of... medical devices. + Work with quality and regulatory teams to ensure maintenance of and compliance… more
    J&J Family of Companies (08/08/25)
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  • Senior Manager, Quality - Combination Products,…

    Gilead Sciences, Inc. (La Verne, CA)
    …plans for QMS improvement + Participate in external industry committees and ensure compliance with applicable medical device and combination product ... reports (MDRs) and provide documented justifications for reportable and non‑reportable regulatory decisions. + Support medical device and combination… more
    Gilead Sciences, Inc. (07/08/25)
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  • Sr Quality Compliance Manager

    Abbott (Pleasanton, CA)
    …Eight (8) years of Quality Systems, Quality Assurance and/or Regulatory Compliance /Affairs experience in medical device manufacturing or other similarly ... understand quality system requirements and how they impact product quality and regulatory compliance . + Represents the division within Abbott through Corporate… more
    Abbott (06/19/25)
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  • Spec, Quality Compliance

    BD (Becton, Dickinson and Company) (Irvine, CA)
    …knowledge of medical terms and human anatomy + Full knowledge of Medical Device Reporting regulations, and regulatory reporting regulations + Good ... and other departments/business units for complaint investigations + Evaluate complaints for Medical Device Reporting (MDR) + Prepare and submit MDR reports… more
    BD (Becton, Dickinson and Company) (08/09/25)
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  • Sr. Quality Compliance Specialist

    Abbott (Alameda, CA)
    …quality-related field. + 5+ years of experience in quality assurance or regulatory compliance in the medical device industry. + Strong knowledge of ISO ... critical in maintaining a state of continuous inspection readiness and ensuring compliance with applicable regulatory requirements, including ISO 13485 and… more
    Abbott (06/29/25)
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  • Senior Compliance Software Engineer…

    Abbott (Alameda, CA)
    …they apply to the development, verification, validation, use, and maintenance of medical device software. + Coordinate activities with other engineering ... to the development, verification, validation, and maintenance of application in support of medical device software. + Software Quality lead in various phases of… more
    Abbott (06/06/25)
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