- 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
- Cedars-Sinai (Los Angeles, CA)
- …all federal and local agencies, including the Food and Drug Administration ( FDA ) and local Institutional Review Board. Primary Duties and Responsibilities: + ... Ensures all data practices comply with federal/local regulations, including FDA , IRB, and Good Clinical Practice (GCP) guidelines. **Qualifications** **Education:**… 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
- UCLA Fielding School of Public Health (Los Angeles, CA)
- …and preclinical PET biomarkers in compliance with internal procedures, cGMP, other FDA regulations and United States Pharmacopeia standards. The candidate is also ... students the fundamentals of clinical grade radiolabeled biomarker production and FDA compliant procedures and operations. Interested candidates should submit their… 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
- J&J Family of Companies (Santa Clara, CA)
- …in full compliance with the company's Design Control requirements and consistent with FDA , ISO, and MDD/MDR requirements + Prototype and develop proof of concept ... Support company goals and objectives, policies and procedures, Quality Systems, and FDA regulations + Other duties as assigned **Requirements** + Bachelor's degree… more
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- …quality assessments, medical device reporting and health risk assessments to the FDA and other regulatory bodies + Provide subject matter expertise into design ... of clinical trials for medical device development and submission to the FDA and other regulatory bodies + Identify and communicate key development goals and… more
- Abbott (Alameda, CA)
- …development, verification, and validation under guidance. + Adhere to FDA -compliant Design Control procedures for software development. + Demonstrate proficiency ... lifecycle development processes that are consistent with ISO, IEEE, or other FDA recognized standards. + Knowledge of design controls and regulations for medical… more
- AbbVie (Pleasanton, CA)
- …discipline. Must have 1 year of quality engineering work experience in FDA regulated medical device manufacturing environment(s). If experience required, must have 1 ... mechanical drawings & GD&T + performing daily assigned tasks in compliance with FDA 's Quality System Regulation (QSR), ISO 13485, ISO 14971, MDR, & MDSAP; +… more