- 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
- US Tech Solutions (San Bruno, CA)
- …and corporate requirements. **Regulatory Compliance:** 1. Ensure compliance with US FDA Quality System Regulations, ISO 13485, and integration of best practices ... with SDLC processes and Quality Management Systems (QMS) compliant with US FDA regulations and ISO 13485. **Tool Proficiency:** 1. Demonstrated ability to… more