- Abbott (Pleasanton, CA)
- …address regulatory, compliance, and quality issues. + Actively participate in FDA inspections and lead internal/corporate audits, notified body audits and applicable ... work environment. + Comply with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, processes,… more
- Envista Holdings Corporation (Pomona, CA)
- …the current process and process changes. + Maintains a working knowledge of FDA GMP, ISO 13485 standards and other applicable standards. + Documents data obtained ... statistical software (Minitab, JMP, etc.) + Certified Quality Engineer preferred. + FDA Quality System Regulation Part 820 and ISO 13485 experience highly desired… more
- Fortive Corporation (Irvine, CA)
- …of new technologies for potential products following the regulatory guidelines / standards ( FDA , TGA, ISO, EU MDR etc.). Ensures that projects and experiments are ... preferred. Professional experience in a GxP-regulated industry and understanding of QSR, FDA , and ISO guidelines is preferred. Working experience with sterilants and… more
- Stanford Health Care (Redwood City, 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
- Edwards Lifesciences (Irvine, CA)
- …MEDDEV 2.7/1 and EU MDR for clinical evaluations. + Familiarity with FDA PMA applications. + Good knowledge of scientific research methodology, device development ... process, GCP, ICH guidelines and Global (US FDA , EU MDR) regulations. + Experience working in a cross functional, collaborative environment and comfortable… more
- Abbott (Alameda, CA)
- …and maintenance of departmental operating procedures to ensure compliance to relevant FDA , QSR, ISO guidelines, including 21 CFR Part 11 and Abbott Corporate ... experience in Software Quality Assurance and/or Software Testing experience. + Knowledge of FDA QSR, relevant ISO guidelines and 21 CFR Part 11. Has knowledge of… more
- ManpowerGroup (San Diego, CA)
- Our client, a leader in the FDA -regulated pharmaceutical industry, is seeking a Senior Calibration Technician to join their team. As a Senior Calibration Technician, ... Strong background in process and analytical technologies, particularly in FDA -regulated environments. + Excellent communication and problem-solving skills. + Ability… 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
- Globus Medical, Inc. (San Diego, CA)
- …design specifications for new product development + Create and maintain project plans and FDA complaint Design history Files (DHF) for each project + Manage of all ... and market plans + Assist in the writing of regulatory applications to the FDA and other regulatory bodies. + Collaborate with the operations department to setup… more
- AbbVie (Irvine, CA)
- …long-term R&D and innovation strategies. Focus is on pipeline development and the FDA and IRA considerations when assessing strategic approaches. This is not a role ... focused on FDA advertising and promotional considerations. + Educates other AbbVie legal departments and business stakeholders on emerging laws, regulations and… more