- Kelly Services (Oakland, CA)
- …is responsible for supporting the development and operations team's compliance with FDA , CLIA, CAP, IVDR, and other global regulatory requirements. This position ... or similar experience **Preferred** . Experience managing regulatory filings with the FDA , EU, and other ex-US regulatory bodies is highly preferred. . Experience… 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
- Fortrex (CA)
- …implement and maintain Food Safety and Safety programs within multiple USDA and FDA facilities across a geographic area while effectively promoting the mission and ... internal, customer, third-party auditing, and regulatory requirements including EEOC, OSHA, FDA , Homeland Security, EPA, and USDA. + Review technical problems and… more
- Sutter Health (Yuba City, CA)
- …is consistent with current medical practice, Food and Drug Administration ( FDA ) and drug manufacturers' recommendations, current literature and/or other information ... Security (DHS), Drug Enforcement Administration (DEA), Food and Drug Administration ( FDA ) and United States Pharmacopeia (USP). **Job Shift:** Days **Schedule:**… more
- Abbott (Menlo Park, CA)
- …to respective teams. + Ensure compliance to product specific standards, cGMP, QSR, US FDA , ISO, IEC, UL, EN, and MDD/MDR requirements and solid understanding of the ... management and device design and development. + Experienced in ISO, EU and FDA regulations, standards and guidance as applicable to risk management and device… more
- Stanford Health Care (Palo Alto, CA)
- …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. The RN First Assistant directly assists the surgeon and practices under the supervision of the… more
- Astrix Technology (Irvine, CA)
- …policies and procedures and applicable external requirements and standards, including FDA , ISO 13485, and other worldwide regulatory agencies pertaining to medical ... etc.) + Familiarity with medical device complaint files and quality records + Knowledgeable of FDA regulations, 21 CFR part 820 and Part 803 and ISO 13485 standard +… more
- Sysco (Fremont, CA)
- …**Education** + Formal job training in TQM principles, SPC, HACCP concepts, CFIA/ FDA regulations would be beneficial. + Formal quality and sensory analysis training ... years of meat and/or seafood industry (as appropriate) experience at a federal CFIA/ FDA meat and/or seafood processing plant (as appropriate). + Raw meat or seafood… more
- University of Southern California (Los Angeles, CA)
- …ongoing assessment of protocol deviations and violations. 4. Participates in NCI, FDA and pharmaceutical audits and is knowledgeable of their regulations, especially ... are recorded correctly and accurately. If Serious Adverse Events are experienced, follows FDA guidelines for prompt reporting within 24 hours. e. If requested will… more
- Cordis (Santa Clara, CA)
- …to improve product quality. + Support regulatory compliance by ensuring adherence to FDA and other relevant standards. + Conduct internal and external quality system ... or equivalent combination of education and experience preferred + Expertise in the FDA and International Medical Device Quality System Regulations and ISO 13485 +… more