- Abbott (Sylmar, CA)
- …and other regulatory requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, ... experience and demonstrated use of Quality tools/methodologies. + Detailed knowledge of FDA , GMP, ISO 13485, and ISO 14971 Solid communication and interpersonal… more
- Abbott (Pleasanton, CA)
- …and product and technology projects + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, ... systems (hardware, electrical, mechanical and software) + Working knowledge of FDA 510(k) and/or EU MDR regulatory requirements + Program/Project Management… more
- Abbott (Pleasanton, CA)
- …lead quality system improvement activities. + Comply with US Food and Drug Administration ( FDA ) regulations, EUMDR, and other regulatory requirements and ... or an equivalent combination of education and experience. + Knowledge of FDA regulations and guidance, ISO 13485, ISO 14971, Software Standards (eg, 62304),… more
- Cedars-Sinai (Los Angeles, CA)
- …Ensures compliance with all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board. + Maintains ... 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
- Abbott (Sylmar, CA)
- …and other regulatory requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, ... and issue-tracking tools such as GIT, Jira, Subversion, ClearQuest, Doors, Bugzilla. + Knowledge of FDA 21 CFR part 820, 21 CFR part 11, GMP, IEEE 1012, IEC 62304… more
- Cedars-Sinai (Los Angeles, CA)
- …Ensures compliance with all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board. + Maintains ... 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
- J&J Family of Companies (Santa Clara, CA)
- …containment and counter measures. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements (ISO), Company ... outcome. + Experience working in regulated product and manufacturing environments (ISO, FDA , cGMP). + Knowledge of and compliance with applicable Quality System… more
- Cedars-Sinai (Los Angeles, CA)
- …compliance with all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board. *Maintains research ... 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
- Gilead Sciences, Inc. (Foster City, CA)
- …storage policies, and sample lifecycle planning. + Thorough knowledge of Food & Drug Administration ( FDA ) and European Medicines Agency (EMA), and other ... applicable national regulations, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines and Good Clinical Practice (GCP) governing the conduct of clinical studies. + Proven ability to effectively… more
- Charles River Laboratories (Carlsbad, CA)
- …worked on 80% of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to providing benefits that ... in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will...bottle /automatic water line and cage checks; provide appropriate food and water; perform cage changing and/or cage cleaning… more