- Abbott (Alameda, CA)
- …volume handheld electronic products. + Extensive knowledge and understanding of GxP , ISO and medical device regulations and the development/implementation of new ... products/processes in a regulated environment. + Extensive experience working in cross functional team environments is required. + Strong technical experience in Electrical engineering discipline. **Preferred Qualifications** + 5+ years of experience with… more
- Amgen (South San Francisco, CA)
- …a research laboratory or vivarium. + **Regulatory knowledge:** Experience handling GxP data and system validation. Knowledge of regulatory requirements affecting ... laboratory data (eg, FDA 21 CFR Part 11, GLP, GCP). + **Scientific Software Expertise** : Experience using or supporting platforms from scientific software providers such as Genedata, StudyLog, Revvity, Proscia, Thermo, Benchling, IDBS, Biovia, etc. + **AI Use… more
- Abbott (Alameda, CA)
- …volume handheld electronic products. + Extensive knowledge and understanding of GxP , ISO and medical device regulations and the development/implementation of new ... products/processes in a regulated environment. + Extensive experience working in cross functional team environments is required. + Strong technical experience in Electrical engineering discipline. **Preferred Qualifications** + 8+ Years of experience with… more
- Terumo Neuro (Aliso Viejo, CA)
- …Standardization (ISO) 14155 and 13485), Health Canada, EU MDR, ICH GCP (E6), GxP Guidelines and Regulations. 5. Advanced working knowledge of QA principles including ... Quality Risk Management (QRM), Critical Thinking, and Quality by Design (QbD). 6. Strong knowledge of compliance risks and quality controls. 7. Experience in adult education and/or training clinical research personnel. 8. Investigational medical device and/or… more
- Gilead Sciences, Inc. (Foster City, CA)
- …clinical supply chain best practices and experience working with a GxP environment. Has strong cross-functional, multi-cultural awareness and communication skills to ... lead in a fast-paced, global company. **ESSENTIAL JOB FUNCTIONS &** **FOCUS AREA:** + Serves as the clinical supply lead on PDM sub-teams especially for complex development programs - eg, late phase, acquisition, partnership/alliance, new modality, etc.). +… more
- Fortive Corporation (Irvine, CA)
- …reprocessing of medical devices is strongly preferred. Professional experience in a GxP -regulated industry and understanding of QSR, FDA, and ISO guidelines is ... preferred. Working experience with sterilants and disinfectants is preferred. Fortive Corporation Overview Fortiveʼs essential technology makes the world stronger, safer, and smarter. We accelerate transformation across a broad range of applications including… more