- Fujifilm (Sacramento, CA)
- …+ Advise, counsel and report to management on general legal risks and regulatory risks, including with respect to FDA regulations and other regulations ... vendor agreements, non-disclosure agreements, development, manufacturing and service agreements, quality agreements and clinical trial and research agreements, among… more
- Gilead Sciences, Inc. (Foster City, CA)
- …role supports regulatory inspections, readiness, and partners with the R&D Quality Extended Leadership team with responsibilities for helping build and shape ... to project teams. + Develop, drive, or support continuous improvements in R&D quality processes, systems, and standards to meet regulatory requirements and… more
- Abbott (Milpitas, CA)
- …highly desirable + Detailed experience with medical device development processes and FDA 510K and PMA regulatory requirement **Preferred Qualifications** + Good ... the development, verification, ensuring timely delivery and adherence to FDA -compliant design control procedures. They provide technical leadership, mentoring, and… more
- Abbott (Alameda, CA)
- …is highly desirable + Detailed experience with medical device development processes and FDA 510K and PMA regulatory requirement + Preferred team leadership ... the development, verification, ensuring timely delivery and adherence to FDA -compliant design control procedures. They provide technical leadership, mentoring, and… more
- Abbott (Alameda, CA)
- …design experience preferred + Detailed experience with medical device development processes and FDA 510K and PMA regulatory requirement and process is desirable. ... development, verification, and validation; responsible for on-time delivery of high- quality embedded software biowearable products that meet budgetary objectives. +… more
- Amgen (Thousand Oaks, CA)
- …will collaborate closely with cross-functional teams including clinical operations, biostatistics, regulatory affairs, and quality to drive data integrity and ... lead Amgen's Clinical Data Management function within GDO, ensuring the highest quality of clinical data collection, processing, and analysis to support … more
- Element Materials Technology (Santa Fe Springs, CA)
- …all experiments and observations + Assist in audit preparedness and for participating in quality audits with FDA , other Regulatory Agencies, and customers, ... II** is responsible for performing testing in a pharmaceutical Quality Control laboratory. All work will be conducted in...testing to meet client requirements and in accordance to regulatory and company guidelines. Set up and confirm suitable… more
- BeOne Medicines (Emeryville, CA)
- General Description: This position within R&D Quality is a senior Auditor role (as Lead or Co-auditor) who is responsible for independently overseeing and conducting ... GCP regulations and industry standards, in accordance with applicable regulatory requirements, guidelines, laws and internally established standards and practices.… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …activities. By working successfully across functions-including Program Management, Marketing, Regulatory , Quality , and Medical Affairs-this leader will ensure ... activities. By working successfully across functions-including Program Management, Marketing, Regulatory , Quality , and Medical Affairs-this leader will ensure… more
- BeOne Medicines (Emeryville, CA)
- …communication and influence with internal stakeholders (eg, clinical development, medical, regulatory , labeling) and external stakeholders (eg FDA , MHRA, EMA, ... signals, evaluation of safety data, assessment of safety risks, responses to regulatory inquiries, and regulatory -required periodic reporting. Physicians in this… more