- Vera Therapeutics (Brisbane, CA)
- …clinical trial readiness, including compliant labeling, packaging, and documentation for regulatory submissions . * Maintain audit readiness and lead ... with a strong focus on vendor selection and performance management, regulatory compliance, risk mitigation, contract oversight & management and operational… more
- Cedars-Sinai (Los Angeles, CA)
- …for completing case report forms, entering clinical research data, and assist with regulatory submissions to the IRB. Provides limited patient contact as needed ... or patient contact for long term follow-up patients only. Assists with regulatory submissions to the Institutional Review Board (IRB) and works closely with… more
- Cedars-Sinai (Los Angeles, CA)
- …for completing case report forms, entering clinical research data, and assist with regulatory submissions to the IRB. Provides limited patient contact as needed ... contact for long term follow-up patients only. + Assists with regulatory submissions to the Institutional Review Board (IRB) including submission of Adverse… more
- J&J Family of Companies (Irvine, CA)
- …and improve user experience. . Responsible to work cross functional to support regulatory submissions and responses. . Develops actionable insights for research ... human factors engineering process, including research, planning, risk assessment, and regulatory submissions . . Demonstrated ability to negotiate with… more
- Actalent (Santa Clara, CA)
- …releasing design change orders. + Provide oversight on proper documentation for regulatory submissions . Essential Skills + Medical device experience and ... devices. + Experience with DHF, firmware, change orders, quality inspection plans, regulatory submissions , and design control. + Experience working with complex… more
- Cedars-Sinai (Los Angeles, CA)
- …for completing case report forms, entering clinical research data, and assist with regulatory submissions to the IRB. Provides limited patient contact as needed ... contact for long term follow-up patients only. + Assists with regulatory submissions to the Institutional Review Board (IRB) including submission of Adverse… more
- Cedars-Sinai (Los Angeles, CA)
- …for completing case report forms, entering clinical research data, and assist with regulatory submissions to the IRB. Provides limited patient contact with ... or contact for long term follow-up research participants only. *Assists with regulatory submissions to the Institutional Review Board (IRB) and works… more
- Cedars-Sinai (Los Angeles, CA)
- …for completing case report forms, entering clinical research data, and assist with regulatory submissions to the IRB. Provides limited patient contact as needed ... or patient contact for long term follow-up patients only. *Assists with regulatory submissions to the Institutional Review Board (IRB) including submission… more
- Abbott (Sylmar, CA)
- …and submission strategies for new FDA 510(k) AI-based SaMD modules. Support international regulatory submissions . + Ensure AI solutions comply with relevant ... regulatory standards and collaborate with Regulatory Affairs to support submission strategies and post-market surveillance. + Conduct risk assessments and develop… more
- Kelly Services (South San Francisco, CA)
- … documentation, effectively gathering and presenting scientific data for global regulatory submissions . + External Partnership Management: Oversee productive ... of CMC, you'll be instrumental in overseeing API process scale-up, regulatory strategy, and operational excellence required for clinical and commercial success.… more