- 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
- Fortive Corporation (Irvine, CA)
- …productivity. Ensure all designs and projects are compliant with GMP, FDA , ISO 13485, and applicable regulatory requirements. **Required Qualifications:** Bachelor's ... Familiarity with industry codes and standards (ASME, ASTM, ISO, FDA ). Excellent analytical, problem-solving, and project management skills. Strong communication… more
- Fujifilm (Sacramento, CA)
- …when Fuji Dictation software is utilized. + Maintains a clear understanding of FDA requirements and ACR recommendation as well as local state regulations for ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all… more
- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …plasma derived pharmaceuticals. + Strict adherence to procedures and practices according to FDA regulations. + Strong emphasis on documentation according to FDA ... regulations. + Adhere to departmental corporate safety policies. + Responsible for facility and equipment cleaning. + All work is performed in a clean room (sanitized) manufacturing environment. + Responsible for performing the following daily tasks: cleaning/… more
- IQVIA (San Francisco, CA)
- …make a significant impact in the field. A strong background in current FDA regulatory expectations and the global landscape in Rare Disease or Pediatrics. Experience ... be given to candidates with recent previous health authority experience (current or ex- FDA medical reviewers, etc.) and with strong a ba_** **_ckgroun_** **_d in_**… 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
- Stanford Health Care (Palo Alto, 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. + After appropriate training, assists the supervising physician in the operating room (OR). + Acts as first or second assistant under the supervision of an approved supervising… more
- Gilead Sciences, Inc. (Foster City, CA)
- …development from early development to commercial launch, filing experience with FDA /EMA, and in-depth technology understanding for biological products are the key ... comprehensive control strategies for biologics products. + Well versed in FDA and ICH guidelines relating to registration, quality, and compliance concerning… 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
- Gilead Sciences, Inc. (Foster City, CA)
- …relationships + Understanding of the pharmaceutical payer marketing that includes FDA regulatory and legal environment (PIE, FDAMA-114, etc.) + Proven ... preferred + Understanding of the pharmaceutical payer marketing that includes FDA regulatory and legal environment (PIE, FDAMA-114, etc.) + Computer aptitude… more