• Labeling Specialist (Med Device)

    Actalent (San Diego, CA)
    …Labeling Specialist to oversee 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 strong understanding of regulatory standards to ensure all labeling materials meet specifications and compliance requirements.  Key Responsibilities: + Lead the development and revision of product labeling, including… more
    Actalent (08/23/25)
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  • Staff Regulatory Affairs Specialist (Hybrid)

    BD (Becton, Dickinson and Company) (San Diego, CA)
    …related Regulatory and Regulatory Operations experience in medical devices and/or in vitro diagnostic field + Experience in Regulatory and Quality Information ... Management systems such as SAP, RIM, Veeva, Sharepoint or related systems + Working experience on creating dashboards and data analysis using tools like power BI. Knowledge and Skills + Working knowledge Regulatory Systems implementation + Ability to manage… more
    BD (Becton, Dickinson and Company) (08/09/25)
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  • Quality Engineer, Design Control

    Hologic (San Diego, CA)
    …FDA 21 CFR 820, ISO 13485 as well as CE mark requirements, In Vitro Diagnostic Regulation (EU) 2017/746 and Medical Device Regulation (EU) 2017/745, Risk ... Management ISO 14971, and other applicable quality and regulatory standards. + Extensive experience and understanding of design, development, verification, and validation processes. + Strong knowledge of scientific principles and concepts. **So why join… more
    Hologic (07/03/25)
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  • Supplier Quality Auditing Manager

    Hologic (San Diego, CA)
    …+ Clean driver's license + Proficient knowledge of Medical Device Regulations, In Vitro Diagnostic Regulation, cGMP, CFR 820, ISO-13485, ISO-14971, ISO-9001 + ... Experience with PPAP (plus) **Skills:** + Expertise in various validation methods and evaluation criteria + Advanced understanding of process transfer, materials control, change control, manufacturing processes, and product testing + Proficient in interpreting… more
    Hologic (06/24/25)
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