- Abbott (Alameda, CA)
- …Implement approved design control procedures for software development in accordance with FDA guidelines. + Play a critical role in software development projects, ... + Solid knowledge of regulations for medical device development, (EN460001, ISO13485, FDA ) is desirable. + Experience in model based design (UML or SysML),… more
- Stanford University (Stanford, CA)
- …events and ensure timely regulatory filing. Ensure compliance with HIPAA, GCP, and FDA regulations as applicable. + Own operational readiness for trial launch and ... executing randomized controlled trial treatment studies. + Experience with FDA regulatory procedures and reporting. + Demonstrated experience with regulatory… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …+ Develop, implement, and maintain design control procedures, ensuring compliance with FDA QSR, ISO 13485, MDR, and other relevant regulatory requirements. + Act ... plans. + Participate in internal and external audits, including FDA inspections, Notified Body audits, and customer audits. +...practical application of medical device regulations and standards, including FDA 21 CFR Part 820 (QSR), ISO 13485, ISO… more
- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …with departmental procedures. + Strict adherence to procedures and practices according to FDA regulations. + Strong emphasis on documentation according to FDA ... Related warehouse and inventory control experience in a pharmaceutical, GMP, or FDA regulated environment is preferred. + Requires a basic understanding of material… more
- Kelly Services (Lodi, CA)
- …11 platform, ensuring manufacturing stays state-of-the-art and compliant with FDA regulations.** **Key Responsibilities:** + Upgrade PC-based control systems to ... by executing Installation and Operational Qualification (IQ/OQ) protocols consistent with FDA regulations. + Work with applications such as Rockwell FactoryTalk View… more
- Stanford University (Stanford, CA)
- …for multiple studies. Complete annual reports to Institutional Review Board, CSTA, FDA and other regulatory agencies. Submit Investigational New Drug applications to ... the FDA as required. + Audit operations, including laboratory procedures,...and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical… more
- Lilly (San Diego, CA)
- …with current local and international regulations, laws, guidance's (for example, FDA , ICH, CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly ... + Support/assist in the preparation of regulatory reports, including NDAs, FDA annual reports and Periodic Adverse Drug Experience Reports (PADERS), preparation… more
- Stanford Health Care (Palo Alto, CA)
- …has been in treating B-cell lymphoma, where CAR T-cell therapy has become an FDA -approved standard of care. We are now expanding our efforts to develop cell ... Prescribing of Drugs; Formulary Protocol] Medications that are not FDA -approved or are used for a non- FDA -...not FDA -approved or are used for a non- FDA - approved indication (off-label use) require a patient-specific order… more
- Terumo Neuro (Aliso Viejo, CA)
- …execution and operational excellence in accordance with ICH Good Clinical Practices, FDA regulations, guidance documents, and company SOPs. Provide oversight of site ... protocol, GCP, company SOPs, and all applicable regulations (eg, FDA ). + Understand, read, prepare, and deploy study documentation...4 weeks a month (75%-100%) 5. Strong knowledge of FDA regulations for clinical trials and clinical procedures. 6.… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …products and drug-device combination products. Ensure compliance with global regulations ( FDA , EMA, ICH, WHO) and anticipate regulatory changes impacting CMC ... for investigational, marketed product submissions (IND/IMPD/NDA/MAA/DMF, post-approval supplements) for FDA and equivalent submissions for Europe and Canada. +… more