- UCLA Health (Los Angeles, CA)
- …The role requires maintaining all necessary documentation in accordance with FDA regulations, Good Clinical Practice (GCP) guidelines, and the funding source. ... and accurate completion of protocol-required procedures according to regulatory guidelines, FDA CFR, GCP, and institutional best practices is essential. Hourly… more
- Abbott (Pomona, CA)
- …validated rooms and equipment. **WHAT YOU'LL DO** + Applies basic understanding of FDA , ISO and cGMP theories and principles. + Contribute to Group's objectives by ... implementation and effectiveness of Abbott Quality Management System per ISO, FDA , and other regulatory agencies. + Responsible for exhibiting professional behavior… more
- Rady Children's Hospital San Diego (San Diego, CA)
- …compliance with regulatory and accrediting agency requirements including but not limited to AABB, FDA , CADPH, JCAHO, CAP and OSHA. Serves as a role model and mentor ... and nonconformances and reports non-conformances meeting requirements directly to the FDA (BPD reporting). MINIMUM QUALIFICATIONS: Bachelor's Degree 5 Years of… more
- Danaher Corporation (Sunnyvale, CA)
- …with effective corrective actions + Support external audit management (eg, FDA , ISO, corporate, foreign governments, etc.,) including pre-audit, during audit, and ... federal regulations and standards including compliance with Food & Drug Administration ( FDA ), ISO 13485, European Union In Vitro Diagnostic Regulation (IVDR) as well… 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
- Cedars-Sinai (Los Angeles, CA)
- …all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board. ESSENTIAL 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
- United Therapeutics (Sacramento, CA)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... + Maintain deep understanding of external patient related guidance documents including FDA guidance on patient focused drug development (PFDD) and patient preference… more
- 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
- Merck (San Diego, CA)
- …across all documentation. + Interact independently with regulatory agencies ( FDA , EMA, etc.), including leading meetings, teleconferences, and written ... leading or supporting direct interactions with major Health Authorities (eg, FDA , EMA). + Demonstrated expertise in leading regulatory filings across global… more
- Element Materials Technology (Santa Fe Springs, CA)
- …and regulatory standards. The role requires a deep understanding of GMP, ISO 17025, FDA , and ICH requirements, as well as the ability to apply these standards to ... years in a supervisory QA role + Strong knowledge of GMP, ISO 17025, FDA , EMA, and ICH guidelines + Experience in reviewing analytical data, method validations, and… more