- ThermoFisher Scientific (Carlsbad, CA)
- …or helping find cures for cancer. **Location/Division Specific Information** Within the Regulatory and Clinical Affairs division, we focus on ensuring that both ... our in vitro diagnostics adhere to Good Clinical Practice (GCP) and relevant regulatory standards (national and international). We also ensure that FDA … more
- Sutter Health (Santa Rosa, CA)
- …requirements with ability to optimize procurement strategies while meeting regulatory requirements + Analyze reports/processes and the administrative functions ... adequate stock levels, checking accuracy of pricing, and completing required regulatory documentation. + Addresses second-level technical and mechanical issues with… more
- Gilead Sciences, Inc. (Foster City, CA)
- …development from early development to commercial launch, filing experience with FDA /EMA, and in-depth technology understanding for biological products are the key ... as an author and reviewer of CMC sections in regulatory filings, and support interactions with health agencies. +...control strategies for biologics products. + Well versed in FDA and ICH guidelines relating to registration, quality, and… more
- Envista Holdings Corporation (Pomona, CA)
- …develop, implement, and maintain quality assurance protocols that comply with regulatory requirements and industry standards. The Sr. Quality Engineer will possess ... a deep understanding of quality management systems, regulatory requirements, and risk management principles. The Sr. Quality...and process changes. + Maintains a working knowledge of FDA GMP, ISO 13485 standards and other applicable standards.… more
- Edwards Lifesciences (Irvine, CA)
- …with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize ... Clinical Science/Medical Writing is responsible for supporting the development of regulatory and clinical documents for a dynamic portfolio of products across… more
- Gilead Sciences, Inc. (Foster City, CA)
- …regarding audit outcomes and CAPAs. Beyond auditing, this role supports regulatory inspections, readiness, and partners with the R&D Quality Extended Leadership ... improvements in R&D quality processes, systems, and standards to meet regulatory requirements and organizational goals while contributing to the overall quality… more
- United Therapeutics (Sacramento, CA)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... + Maintain deep understanding of external patient related guidance documents including FDA guidance on patient focused drug development (PFDD) and patient preference… more
- Cedars-Sinai (Los Angeles, CA)
- …for completing case report forms, entering clinical research data, and assist with regulatory submissions to the IRB. Provides limited patient contact as needed for ... study budget and patient research billing. Ensures compliance with all federal, local, FDA , IRB, and HIPAA guidelines and regulations pertaining to the study and… 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 + ... concerns regarding data quality and study conduct. + Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit… more
- Lactalis American Group Inc. (Tulare, CA)
- …priorities, and drive continuous improvement initiatives. + Working knowledge of regulatory requirements in dairy/food manufacturing ( FDA , USDA, OSHA). + ... implementing process improvements, supporting capital projects, and ensuring compliance with regulatory and safety standards. From your EXPERTISE to ours Key… more