- BeOne Medicines (San Mateo, CA)
- …communication and influence with internal stakeholders (eg, clinical development, medical, regulatory , labeling) and external stakeholders (eg FDA , MHRA, EMA, ... evaluation of safety data, assessment of safety risks, responses to regulatory inquiries, and regulatory -required periodic reporting._ _Physicians in this… 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
- Cedars-Sinai (Los Angeles, CA)
- …Ensures compliance with all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board. + Maintains ... for completing case report forms, entering clinical research data, and assist with regulatory submissions to the IRB. Provides limited patient contact as needed for… 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 ... with effective corrective actions + Support external audit management (eg, FDA , ISO, corporate, foreign governments, etc.,) including pre-audit, during audit, and… 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
- Cedars-Sinai (Los Angeles, CA)
- …Ensures compliance with all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board. Maintains research ... field with groundbreaking, life-saving research. From genetic counseling and targeted drug therapies to a growing array of minimally invasive procedures,… more