- Genentech (South San Francisco, CA)
- …and partnerships; + Advising regulatory , medical affairs, and other clients on FDA regulatory submissions, label negotiations and privacy and data use; + ... product sales and marketing, commercial strategic and operational functions, regulatory , market access (patient access, pricing, contracting and distribution), US… more
- Stanford University (Stanford, CA)
- …regulatory compliance. + Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure ... and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. + Knowledge… more
- Stanford University (Stanford, CA)
- …regulatory compliance. + Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure ... and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. + Knowledge… more
- Stanford University (Stanford, CA)
- …regulatory compliance. + Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure ... and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. + Knowledge… more
- Danaher Corporation (Sunnyvale, CA)
- …local, state, and federal regulations and standards including compliance with Food & Drug Administration ( FDA ), ISO 13485, European Union In Vitro Diagnostic ... . + Participate in external audit management ( eg FDA , ISO, Danaher Corporate, foreign governments), in either a...Regulation (IVDR) as well as other applicable global regulatory requirements, including Medical Device Single Audit Program (MDSAP)… more
- Stanford University (Stanford, CA)
- …regulatory compliance. + Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure ... and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. + Knowledge… more
- Stanford University (Stanford, CA)
- …regulatory compliance. + Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure ... and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. + Knowledge… more
- Stryker (San Jose, CA)
- …improvement across the software lifecycle by implementing software industry best practices and regulatory standards ( FDA , TGA, EUMDR, IT). + Engage in design and ... Google, Microsoft, or similar, demonstrating strong technical skills + Experience with regulatory agencies ( FDA , MoH, TUV) and medical device regulations (820,… more
- Abbott (Sylmar, CA)
- …(EMS), and other regulatory requirements. *Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company ... and process development from concept through sustained manufacturing of FDA regulated products. Responsible for production support, maintenance support, performing… more
- Stanford University (Stanford, CA)
- …regulatory compliance. + Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure ... and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. + Knowledge… more