- 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
- Providence (Orange, CA)
- …data collection, reporting, outcomes, quality improvement, standards/pathways. + Experience in meeting FDA (GCP, ICH guidelines), as well as other Federal, State and ... gene therapy practices. + Experience with working with Pharmaceutical and FDA agency representatives. **Preferred Qualifications:** + Master's Degree **Why Join… 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
- Taiho Oncology (Pleasanton, CA)
- …direct reports. + In-depth knowledge of MedDRA, global labeling requirements ( FDA , EMA, ICH), and safety database management. + Experience with configuration ... Argus). + In-depth knowledge of relevant Food and Drug Administration ( FDA ), European Union (EU) and International Conference on Harmonization (ICH) guidelines,… 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
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …reports. + Ensure compliance with design control procedures, medical device regulations (eg, FDA 21 CFR Part 820, ISO 13485), and company policies. + Contribute to ... actions. Compliance & Audits: + Support internal and external audits (eg, FDA , ISO) by providing documentation and technical expertise related to design quality.… more
- Danaher Corporation (San Diego, CA)
- …including user guides, service guides, and instructions that strictly adhere to FDA , EU MDR/IVDR, and ISO 13485 requirements, ensuring all materials are audit-ready. ... + Strong working knowledge of medical device regulations and quality standards, including FDA (21 CFR Part 820), EU IVDR/MDR, and ISO 13485. + Demonstrated expertise… more