- Cytel (Sacramento, CA)
- …+ Maintain strong engagement with senior client leadership, regulatory agencies ( FDA /EMA), and key opinion leaders to support and refine development strategies. ... driving high-impact consulting engagements. + Experience interacting with regulatory agencies ( FDA /EMA) and key opinion leaders to shape and enhance development… more
- Cedars-Sinai (Beverly Hills, CA)
- …all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board (IRB). Primary Duties and 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
- Abbott (Pomona, CA)
- …to the development, implementation and effectiveness of Quality Management System per ISO, FDA , and other regulatory agencies. + Perform other duties and projects as ... scheduling. **Preferred Qualifications** + An engineering or science background in FDA regulated industry. + Experience with root cause analysis, failure mode… more
- Stanford Health Care (Palo Alto, CA)
- …Furnishing or Prescribing of Drugs; Formulary Protocol] Medications that are not FDA -approved or are used for a non- FDA -approved indication (off-label use) ... require a patient-specific order in advance from the supervising physician. + After appropriate training, assists the supervising physician in the operating room. The RN First Assistant directly assists the surgeon and practices under the supervision of the… more
- Dairy Farmers of America (Riverside, CA)
- …and test results - Ensure compliance with regulatory requirements, such as FDA regulations and HACCP guidelines - Assist in the development and implementation ... skills to maintain accurate documentation of quality records - Understanding of FDA regulations and HACCP guidelines If you are a dedicated professional with… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …the pharmaceutical, biotech, or CRO industry. + In-depth knowledge of ICH-GCP, FDA , EMA, and other global regulatory requirements related to clinical research. + ... + Experience working with CROs or external vendors. + Exposure to FDA or other health authority inspections. **Competencies** **Accountability for Results -** Stay… more
- Mentor Technical Group (South San Francisco, CA)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... overseeing work order activity compliance with respective regulatory requirements (ie FDA , DEA, OSHA). + Manage Work through the Computerized Maintenance Management… more
- Stanford Health Care (Palo Alto, CA)
- …the consent process to ensure it is performed in compliance with institutional, FDA , IRB, clinical trial sponsor and other applicable regulations. + Oversees and ... guidelines, policies and procedures when providing care. Ensures adherence to GCP, ICH, FDA and other regulatory agencies in the conduct of clinical research. +… more
- Terumo Neuro (Aliso Viejo, CA)
- …submission activities focused on US/EU/Canada and for ensuring compliance to FDA and international regulatory agency requirements for Neurovascular and Peripheral ... a week 4. Strong technical writing skills as evidence by multiple successful US FDA Class II / III medical device submissions, EU CE Mark applications, Health Canada… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …quota management, recordkeeping, and reporting. + Working knowledge and understanding of FDA /ICH/USP requirements, including FDA 21 CFR Parts 210, 211, and ... Part 11 (and Part 820, if applicable), ICH Q7 + Strong understanding of GMP requirements and global regulatory expectations for controlled substances. + Experience managing quality systems (eg, deviations, CAPA, change control, complaints) in a regulated… more