- 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
- ABM Industries (Irvine, CA)
- …the development, implementation and effectiveness of Quality Management System per ISO, FDA , and other regulatory agencies. Understands and is aware of the quality ... Remain knowledgeable of current federal and international regulations, including FDA 21CFR part 820, FDA 21CFR part 11, and ISO 13485. Maintain working knowledge… more
- Oracle (Sacramento, CA)
- …Clinical Evaluation Reports (CERs), including alignment with EU MDR and FDA regulatory requirements. . Oversee usability engineering (IEC 62366), ensuring ... Knowledge of ISO 14971, IEC 62366, EU MDR/IVDR, and FDA guidance related to medical device software (SaMD). ..... Experience supporting regulatory submissions or audits (EU MDR, FDA 510(k), etc.). . Experience working with AI-driven medical… more
- Oracle (Sacramento, CA)
- …applying medical device standards (including IEC 62304, IEC 82304, and FDA guidance), define software interfaces, manage traceability across the system lifecycle, ... device software, ensuring vulnerability management and cybersecurity compliance with FDA and global regulatory expectations. + Apply the organization's Risk-Based… more
- Hologic (San Diego, CA)
- …in supporting quality activities related to Design Control efforts in accordance with FDA , ISO, and other IVD regulations. You will also support the company's ... quality system activities and design comply with the FDA 's Quality System Regulations (QSRs), ISO 13485, and applicable...knowledge of Quality Management System for Medical Device Manufacturing FDA 21 CFR 820, ISO 13485 as well as… more
- Cedars-Sinai (Los Angeles, CA)
- …all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board (IRB). **Primary Duties & Responsibilities** + ... with all federal and local agencies including the Food and Drug Administration ( FDA and local Institutional Review Board. + Maintains research practices using Good… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …skills, excellent customer service abilities, and meticulous documentation practices in an FDA -regulated environment. This is a remote role with overnight hours to ... organizational capabilities + Ability to follow procedures in an FDA -regulated environment **Required Qualifications** + High School Diploma (minimum education… more
- Grifols Shared Services North America, Inc (Van Nuys, CA)
- …state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedures, Occupational Safety and Health Administration (OSHA), ... state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedures, Occupational Safety and Health Administration (OSHA),… more