- 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. IRB… more
- Stanford Health Care (Redwood City, CA)
- …Ordering, 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. + 10. After appropriate training, assists the supervising physician in the operating room (OR). + a. Acts as first or second assistant under the supervision of an approved… more
- Stryker (San Jose, CA)
- …test execution with design and product goals. + Ensure compliance with FDA and ISO 13485 standards through robust test documentation and disciplined verification ... with GoogleTest, CppUnit, or similar automated test frameworks. + Understanding of FDA and ISO 13485 medical device compliance requirements. + Experience with… more
- Cedars-Sinai (Los Angeles, CA)
- …and local agency requirements including the Food and Drug Administration ( FDA ) and local Institutional Review Board. **Primary Job Duties and Responsibilities** ... all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board. + Maintains research practices using Good… more
- Gilead Sciences, Inc. (Foster City, CA)
- …distribution + Host/Support NAPB audits of Asegua as well as supporting external FDA audits and internal audit programs, as required + Generate & maintain Standard ... manufacturing environment. + Experience in US market to include supporting FDA inspections. + Demonstrates proficiency in Good Distribution Practices (GDP), and… more
- J&J Family of Companies (Santa Clara, CA)
- …counter measures. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements (ISO), Company policies, operating procedures, ... outcome. + Experience working in regulated product and manufacturing environments (ISO, FDA , cGMP). + Knowledge of and compliance with applicable Quality System… more
- Gilead Sciences, Inc. (Foster City, CA)
- …interacts closely with external regulators/stakeholders as well as supporting external FDA audits and internal audit programs + Participate in developing/approving ... manufacturing environment. + Experience in US market to include supporting/hosting FDA inspections. + Demonstrates proficiency in Good Distribution Practices (GDP),… more
- Stanford Health Care (Palo Alto, CA)
- …clinic staff on pharmacy-related issues such as regulatory changes/compliance, FDA drug recalls, drug information, special programs, sample medications, ... levels. + Knowledge of other relevant regulatory guidelines (eg, CMS, 340B, FDA ). + Knowledge of theories, principles, practices and techniques of personnel… more
- US Tech Solutions (San Bruno, CA)
- …and US and International Medical Device Regulations & Regulatory Agencies (eg, FDA , Notified Bodies, etc.), and regulatory audits. + Performing product qualification ... of work. + Experience with medical device development standards eg ISO 13485, FDA 21 CFR 820 + Experience working with products incorporating hardware, firmware and… more
- Edwards Lifesciences (Irvine, CA)
- …MEDDEV 2.7/1 and EU MDR for clinical evaluations. + Experience with FDA PMA applications. + Strong knowledge of scientific research methodology, device development ... process, GCP, ICH guidelines and Global (US FDA , EU MDR, Japan PMDA, China NMPA) regulations. + Experience working in a cross functional, collaborative environment… more