- 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
- Abbott (Alameda, CA)
- …+ Develops and maintains departmental operating procedures to ensure compliance to relevant FDA QSR, ISO guidelines, including 21 CFR Part 11 and Abbott Corporate ... software validation experience in a medical device company + Knowledge of FDA QSR, ISO13485, ISO14971 and IEC62304 **Preferred Qualifications** + Knowledge of Jira,… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …content is accurate, current, and aligned with global regulatory requirements ( FDA , EMA, ICH). **Compliance & Risk Management** + Monitor training compliance ... + Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA , EMA, etc.). + Proven ability to design and deliver impactful learning programs… more
- Astrix Technology (Chino, CA)
- …compliance with all applicable food safety and quality regulations (eg, GMP, HACCP, FDA , USDA). + Promote a culture of safety, quality, and continuous improvement. + ... role. + Strong working knowledge of food safety programs and regulatory requirements ( FDA , USDA, HACCP, GMP, etc.). + Familiarity with food labeling regulations and… 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
- Bayer (Berkeley, CA)
- …including a current understanding of USP/EP, cGMP regulations, ICH, and FDA Guidance Documents. Provide support during internal/external audits; * Ability to ... management, Risk Management, etc.); + Expertise in cGMP and regulatory requirements ( FDA , EMA, ICH, etc.); + Expertise in performing investigative work; + Knowledge… more
- BD (Becton, Dickinson and Company) (Irvine, CA)
- …and presentations. Conduct verification and validation testing in accordance with FDA and ISO standards. Support regulatory submissions by documenting algorithm ... delivery systems, mechanical ventilators and anesthesia delivery systems. Experience with FDA design controls and IEC software lifecycle processes. Knowledge of… more
- GRAIL (Menlo Park, CA)
- …author regulatory plans and activities to optimally position GRAIL products with the FDA and/or global health authorities. + Support the US Regulatory Affairs team ... Regulatory affairs and IVD device experience required. + Direct experience with FDA regulatory submissions required. + Demonstrated knowledge of US and international… more
- Norstella (Sacramento, CA)
- …and biotech companies around the world, along with regulators like the FDA , and payers. By providing critical proprietary data supporting AI-driven workflows, ... concepts + Experience in using research tools and databases (eg, ClinicalTrials.gov, EMA, FDA , SEC filings) + High proficiency in MS Office Suite (Excel, Word,… 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