- 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
- Imperative Care (Campbell, CA)
- …electrical safety design and documentation that complies with regulatory requirements of the FDA , UL and TUV (specifically those related to IEC, EMC, CISPR, etc). + ... CISPR22, ISO for safety and EMC compliance in a regulated environment (UL, TUV, FDA ). + Facilitate board bring-up, test, and debug of newly designed printed circuit… more
- Cedars-Sinai (Los Angeles, CA)
- …all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board (IRB). **Primary Duties and Responsibilities:** ... with all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board. + Maintains research practices using Good… 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
- 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.11). 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
- Astrix Technology (Pomona, CA)
- …and nutritional information. + Review and proof labels to ensure compliance with FDA , USDA, and other applicable regulations. + Coordinate with suppliers to collect ... + **Experience working with Genesis and nutritional labels.** + Knowledge of FDA , USDA, AIB, HACCP, GMP, and Allergen Programs. + Strong understanding of… more
- Cedars-Sinai (CA)
- …all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board (IRB). **Primary Duties & Responsibilities** + ... with all federal and local agencies including the Food and Drug Administration ( FDA and local Institutional Review Board. + Maintains research practices using Good… more
- Cedars-Sinai (Los Angeles, CA)
- …all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board (IRB). **Primary Job Duties and ... with all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board. + Maintains research practices using Good… more
- J&J Family of Companies (Santa Clara, CA)
- …and document investigation findings + Participate in internal and third-party audits ( FDA , Notified Body) + Participate in Material Review Board (MRB) meetings ... Experience in the medical device industry is strongly preferred + Knowledge of cGMP, FDA 820 QSR, ISO 13485, or other Quality Systems + Strong technical writing… 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