• Future Opportunities - Join Our Talent Pipeline…

    AbbVie (Pleasanton, CA)
    …with preferably no managerial intervention. Qualifications * BS in Mechanical, Software , Electrical Engineering or equivalent degree. Advanced degree desirable. * ... Requirements: * Responsible for performing all duties in compliance with FDA 's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations,… more
    AbbVie (06/19/25)
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  • Associate Director Regulatory Affairs

    Abbott (San Diego, CA)
    …and software required. + Experience with meeting global (ie, US FDA , IVDR, PMDA) cybersecurity, EMC, and software requirements. + Regulatory history, ... identified, obtained, and effectively presented for product registration worldwide (US, FDA , CE-IVDR, PMDA, etc.). **Strategic Planning:** + Identify and approve new… more
    Abbott (07/10/25)
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  • Associate General Counsel, Senior Director…

    Oura (San Francisco, CA)
    …influence cross-functional teams. The successful candidate will possess expertise in FDA frameworks governing digital health products, including wearable devices and ... related software , including Software as a Medical Device...regulatory compliance with commercial objectives. What you will do: FDA & Global Regulatory Compliance: + Serve as the… more
    Oura (08/17/25)
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  • Staff Specialist Regulatory Affairs (Hybrid)

    BD (Becton, Dickinson and Company) (San Diego, CA)
    …determine whether submissions or notifications are required. + Ensure SaMD compliance with FDA guidance on Clinical Decision Support (CDS) software and other ... frameworks, Agile SDLC, experience with cross functional team transactions, and various FDA SW related guidance's and industry best practices. The role involves… more
    BD (Becton, Dickinson and Company) (08/21/25)
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  • Lead Product Security Engineer (R&D Cytology)

    Hologic (San Diego, CA)
    …gain immense satisfaction by enabling healthier lives everywhere, every day. Our Software Engineering (R&D) department in our Diagnostics division is looking for a ... representative ensuring that our products are meeting industry standards and FDA requirements throughout the product lifecycle, including post-market. This is a… more
    Hologic (08/22/25)
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  • CSV Automation Specialist

    VTI Life Sciences (San Diego, CA)
    …environments are validated in compliance with industry standards, regulatory requirements (such as FDA 21 CFR Part 11 and 820, Data Integrity, ISO 13485 and GAMP ... the lifecycle of cGxP systems. RESPONSIBILITIES: + Authoring and Executing Software Test Protocols. + Draft, route, and execute Commissioning and Qualification… more
    VTI Life Sciences (08/13/25)
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  • Operations Supervisor - Warehouse & Transfill

    Owens & Minor (Riverside, CA)
    …information, cylinder maintenance and inspection logs and materials required by the FDA * Oversee the shipping, receiving and distribution of USP Medical Oxygen ... logistics, and safety procedures.) * Ensures all Human Resources, Regulatory, Joint Commission, FDA , and Legal training is completed on time and that all internal… more
    Owens & Minor (08/21/25)
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  • Sr. Product Security Engineer (San Diego, CA…

    Abbott (San Diego, CA)
    …and security architecture reviews for embedded medical devices and supporting software . + Collaborate with engineering, quality, and regulatory teams to apply ... risk assessments and contribute to risk mitigation strategies aligned with FDA and international cybersecurity guidance. + Implementation of security risk controls… more
    Abbott (08/01/25)
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  • Quality Assurance Manager

    Actalent (Vista, CA)
    …within our organization. This role is critical in maintaining compliance with FDA and ISO standards, managing our Quality Management System (QMS), and ensuring ... product complaints and ensure timely resolution. + Oversee regulatory submissions including FDA 510(k), CE mark, and other product registrations. + File Vigilance… more
    Actalent (08/20/25)
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  • QA Documentation Control Specialist

    Astrix Technology (Rancho Dominguez, CA)
    …and discrepancies as neede + Ensure all documentation complies with applicable FDA , SQF, and other regulatory standards + Assist with identifying and resolving ... with industry standards + Assist with the development of nutritional data using software such as ESHA Genesis **Qualifications:** + Bachelor's degree in Food Science… more
    Astrix Technology (07/28/25)
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