- Cedars-Sinai (Beverly Hills, CA)
- …with all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board (IRB). **What are the Primary 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
- US Tech Solutions (San Bruno, CA)
- …and corporate requirements. **Regulatory Compliance:** 1. Ensure compliance with US FDA Quality System Regulations, ISO 13485, and integration of best practices ... with SDLC processes and Quality Management Systems (QMS) compliant with US FDA regulations and ISO 13485. **Tool Proficiency:** 1. Demonstrated ability to… 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
- Cedars-Sinai (Los Angeles, CA)
- …for other Clinical Research Associates. Ensures compliance with all federal, local, FDA , IRB, and HIPAA guidelines and regulations pertaining to the study and ... all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board. Maintains research practices using Good… more
- Takeda Pharmaceuticals (Los Angeles, CA)
- …activities for Teardown, Fractionation, and Purification following cGMP, GDDP, FDA and Regulatory Standards, ISO requirements, and internal standard operating ... assessments to support good understanding and knowledge of current regulatory requirements ie, FDA , ISO, and Takeda Quality Systems, and serve as a plant resource… more
- Cedars-Sinai (Los Angeles, CA)
- …study budget and patient research billing. Ensures compliance with all federal, local, FDA , IRB, and HIPAA guidelines and regulations pertaining to the study and ... all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board. *Maintains research practices using Good… more
- Medtronic (Los Angeles, CA)
- …in the operating room, so healthcare/surgical setting experience + Familiarity with FDA product requirements and regulatory guidelines + Experience with robotics or ... Ability to read and understand schematics and engineering drawings + Familiar with the FDA 21 CFR, CGMP for Medical devices + Demonstrable skills in Microsoft Office… more
- BD (Becton, Dickinson and Company) (Brea, CA)
- …Minimum ten (10) years progressive experience in Quality Assurance within an FDA regulated industry; QA administration and planning experience required. + Minimum 3 ... MDR 2017/745, ISO13485, and ISO14971 + Quality system auditing + Management of FDA and notified body audits. + Risk Management + Change control. + Software… more
- Philips (Ontario, CA)
- …areas. The role is site based in Ontario, CA - an air-conditioned FDA regulated manufacturing environment for Medical Devices and Pharmaceutical drugs (ISO 13485). ... **Your role:** + Effectively work in a high volume, fast paced FDA regulated manufacturing environment providing safety orientation and trainings to employees,… more
- Abbott (San Diego, CA)
- …identified, obtained, and effectively presented for product registration worldwide (US, FDA , CE-IVDR, PMDA, etc.). **Strategic Planning:** + Identify and approve new ... instruments and software required. + Experience with meeting global (ie, US FDA , IVDR, PMDA) cybersecurity, EMC, and software requirements. + Regulatory history,… more