- Deloitte (San Francisco, CA)
- …Compliance: Ensure all solutions and processes meet global regulatory requirements (eg, FDA , EMA, PMDA) and industry best practices. + Data Analysis & Reporting: ... (Word, Excel, Power Point) + Knowledge of global regulations and guidelines such as ICH, FDA , EMA, PMDA, etc. + Ability to travel 50%, on average, based on the work… more
- University of Southern California (Los Angeles, CA)
- …ongoing assessment of protocol deviations and violations.4. Participates in NCI, FDA and pharmaceutical audits and is knowledgeable of their regulations, especially ... are recorded correctly and accurately. If Serious Adverse Events are experienced, follows FDA guidelines for prompt reporting within 24 hours. e. If requested will… more
- Charles River Laboratories (Northridge, CA)
- …supported the development of 100% of the current commercially available FDA -approved immunocellular therapies. Our mission is to provide a best-in-class portfolio ... 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 elevate your… more
- 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