- Amgen (South San Francisco, CA)
- …San Francisco, you will join a multi-functional team of scientists and software professionals that enables technology and data capabilities to evaluate drug ... their abilities to affect the biology of drug targets. This team implements software platforms that enable the capture, analysis, storage, and report of in vitro… more
- Abbott (Pomona, CA)
- …validated rooms and equipment. **WHAT YOU'LL DO** + Applies basic understanding of FDA , ISO and cGMP theories and principles. + Contribute to Group's objectives by ... implementation and effectiveness of Abbott Quality Management System per ISO, FDA , and other regulatory agencies. + Responsible for exhibiting professional behavior… more
- Kelly Services (Sunnyvale, CA)
- …(NPD) core teams, working on medium to complicated assay, instrument, software projects and/or system projects. **Responsibilities** + Prepare regulatory submissions ... core teams including medium to complicated assay, instrument or software projects and submissions (510(k), De Novo, Class A,...(US, EU, WHO/PQ). + Authors and prepare regulatory submissions (US- FDA , IVDR, WHO/PQ) as required by project plan. +… more
- Fortive Corporation (Irvine, CA)
- …productivity. Ensure all designs and projects are compliant with GMP, FDA , ISO 13485, and applicable regulatory requirements. **Required Qualifications:** Bachelor's ... medical device, pharmaceutical, or GMP-regulated environment. Proficient in CAD software (SolidWorks preferred), GD&T, and engineering drawing standards. Strong… more
- BD (Becton, Dickinson and Company) (Brea, CA)
- …of the Quality Management Strategic initiatives, such as Inspire Quality. + Software validation + Quality functional support for implementation of electronic systems ... Minimum ten (10) years progressive experience in Quality Assurance within an FDA regulated industry; QA administration and planning experience required. + Minimum 3… more
- Fortive Corporation (Irvine, CA)
- …of new technologies for potential products following the regulatory guidelines / standards ( FDA , TGA, ISO, EU MDR etc.). Ensures that projects and experiments are ... preferred. Professional experience in a GxP-regulated industry and understanding of QSR, FDA , and ISO guidelines is preferred. Working experience with sterilants and… more
- Globus Medical, Inc. (San Diego, CA)
- …design specifications for new product development + Create and maintain project plans and FDA complaint Design history Files (DHF) for each project + Manage of all ... + Design and develop instruments and implants using Pro/E software + Partner with in-house prototype shop and outside...Assist in the writing of regulatory applications to the FDA and other regulatory bodies. + Collaborate with the… more
- Abbott (Sylmar, CA)
- …Work On** + Demonstrates expert knowledge and proficiency of the complete software development process. + Design/Implement software in current OOPs programming ... all features in one or more subsystems. + Debugs, troubleshoots, and isolates software problems as well as provide strategic solutions, analysis, and contribute to… more
- Gilead Sciences, Inc. (Foster City, CA)
- …aspects of clinical trial monitoring. + Uses a variety of advanced statistical software , methods, and techniques to gather, analyze, and interpret research data to ... performs or supervises data entry. + Develops enhancements to statistical software , as appropriate, by programming new techniques; maintains knowledge of current… more
- Medtronic (Santa Rosa, CA)
- …through the full product lifecycle. Bringing hands-on expertise in regulatory software development strategies (SaMD, AI, Machine Learning, Cybersecurity, etc.,) to ... is key. This individual will support maintaining a strong foundation for future software product development for the Regulatory Function and may also support broader… more