- Abbott (Sylmar, CA)
- …requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, processes, ... 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
- Stanford Health Care (Palo Alto, CA)
- …Furnishing or Prescribing of Drugs; Formulary Protocol] Medications that are not FDA -approved or are used for a non- FDA -approved indication (off-label use) ... require a patient-specific order in advance from the supervising physician. + After appropriate training, assists the supervising physician in the operating room. The RN First Assistant directly assists the surgeon and practices under the supervision of the… more
- Stanford Health Care (Palo Alto, CA)
- …Furnishing or Prescribing of Drugs; Formulary Protocol] Medications that are not FDA -approved or are used for a non- FDA -approved indication (off-label use) ... require a patient-specific order in advance from the supervising physician. + After appropriate training, assists the supervising physician in the operating room. The RN First Assistant directly assists the surgeon and practices under the supervision of the… more
- Envista Holdings Corporation (Brea, CA)
- …the current process and process changes. + Maintains a working knowledge of FDA GMP, ISO 13485 standards and other applicable standards. + Documents data obtained ... + 5 years of experience in quality engineering within medical device industry. + FDA Quality System Regulation Part 820 and ISO 13485 experience. + Certified Quality… more
- Abbott (Sylmar, CA)
- …including risk prioritization & mitigation. + Evaluates published Regulatory Agency (eg FDA ) guidance, changes to external standards, actions and audit findings to ... to executive management and staff. + Establishes solid relationship with TUV/BSI/ FDA and other regulatory agencies. Liaison to AQR's External Standards Database,… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …the drug, biologic, and device development process, laws, regulations, and guidelines from FDA , EMA, PMDA, ICH, etc. + General knowledge of global regulations for ... 2-3 years' work experience in regulatory intelligence. + Previous interactions with FDA or other health authority are desirable. **Skills and Competencies:** +… more
- ThermoFisher Scientific (West Hills, CA)
- …& Risk Management** + Ensure the team, process, and systems align with applicable regulations ( FDA , 21 CFR Part 820, Part 11, ISO 13485, IVDR, ISO 17025). + Own or ... assessments (eg, FMEA). + Support internal and external audits (eg, FDA , Notified Bodies). **Multi-Functional Collaboration** + Partner with R&D and Manufacturing… more
- Imperative Care (Campbell, CA)
- …electrical safety design and documentation that complies with regulatory requirements of the FDA , UL and TUV (specifically those related to IEC, EMC, CISPR, etc). + ... CISPR22, ISO for safety and EMC compliance in a regulated environment (UL, TUV, FDA ). + Facilitate board bring-up, test, and debug of newly designed printed circuit… more
- Cedars-Sinai (Los Angeles, CA)
- …all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board (IRB). **Primary Duties and Responsibilities:** ... with all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board. + Maintains research practices using Good… more
- Stanford University (Stanford, CA)
- …investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed. _* - ... protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. +… more