- Terumo Neuro (Aliso Viejo, CA)
- …coordinating clinical research activities in accordance with ICH Good Clinical Practices, FDA guidelines, local regulations, and MicroVention SOPs. Job duties: + As ... and study training documents. + Responsible for collecting and reviewing site regulatory documents. + Manage device accountability process. + Conduct Site Initiation… more
- UCLA Health (Los Angeles, CA)
- …study protocol and applicable regulations, such as institutional policy and procedures, FDA Code of Federal Regulations (CFR), and ICH Good Clinical Practice (GCP). ... manage the preparation of clinical trials budgets. + Expert level experience with FDA processes and procedures. + Demonstrated ability to serve as a subject matter… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …your best self. Become a maker of _possible_ with us. The Director of Regulatory Affairs reports directly to the Senior Director of Regulatory Affairs. This ... Software and Accessories on a global basis from a Regulatory Affairs standpoint. Support will consist of new product...effort to comply with new and existing regulations (eg, FDA Medical Device Regulations, EU-MDR) + Support the monitoring,… more
- Amgen (Thousand Oaks, CA)
- …quality of clinical data collection, processing, and analysis to support regulatory submissions and clinical development programs. This role is responsible for ... collaborate closely with cross-functional teams including clinical operations, biostatistics, regulatory affairs, and quality to drive data integrity and compliance… more
- Gilead Sciences, Inc. (Foster City, CA)
- …improvements in R&D quality processes, systems, and standards to meet regulatory requirements and organizational goals and contribute to the overall quality ... a primary point-of-contact to assigned R&D groups and advise on: GCP regulatory requirements; relevant Gilead policies and procedures supporting audits and clinical… more
- Stanford University (Stanford, CA)
- …and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. + Knowledge ... milestones, and invoice sponsors according to study contract. + Ensure regulatory compliance. Regularly inspect study document to ensure ongoing regulatory… more
- Stanford University (Stanford, CA)
- …and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. + Knowledge ... milestones, and invoice sponsors according to study contract. + Ensure regulatory compliance. Regularly inspect study document to ensure ongoing regulatory… more
- Danaher Corporation (Sunnyvale, CA)
- …effective corrective action . + Participate in external audit management ( eg FDA , ISO, Danaher Corporate, foreign governments), in either a supporting or lead role, ... federal regulations and standards including compliance with Food & Drug Administration ( FDA ), ISO 13485, European Union In Vitro Diagnostic Regulation (IVDR) as well… more
- Stanford University (Stanford, CA)
- …and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. + Knowledge ... milestones, and invoice sponsors according to study contract. + Ensure regulatory compliance. Regularly inspect study document to ensure ongoing regulatory… more
- Stanford University (Stanford, CA)
- …and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. + Knowledge ... milestones, and invoice sponsors according to study contract. + Ensure regulatory compliance. Regularly inspect study document to ensure ongoing regulatory… more