- GRAIL (Menlo Park, CA)
- …author regulatory plans and activities to optimally position GRAIL products with the FDA and/or global health authorities. + Support the US Regulatory Affairs team ... Regulatory affairs and IVD device experience required. + Direct experience with FDA regulatory submissions required. + Demonstrated knowledge of US and international… more
- Norstella (Sacramento, CA)
- …and biotech companies around the world, along with regulators like the FDA , and payers. By providing critical proprietary data supporting AI-driven workflows, ... concepts + Experience in using research tools and databases (eg, ClinicalTrials.gov, EMA, FDA , SEC filings) + High proficiency in MS Office Suite (Excel, Word,… 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
- Gilead Sciences, Inc. (El Segundo, CA)
- …teams + Create, revise, and approve LIMS system SOPs and reports per GMP, FDA , EU, Global, and ICH guidelines + Triage and evaluate site change requests, assess ... 5+ years of experience with SQL **Preferred Qualifications** + Strong understanding of FDA , ISO 13485, Medical Device Directive + Prior experience managing a team +… more
- J&J Family of Companies (Santa Clara, CA)
- …requirements, and supporting the Regulatory Affairs team to ensure compliance with FDA , EU MDR, and other relevant regulations. + Collaborate with Johnson & ... operations, and post-market surveillance is required. + Successful history leading FDA inspections, ISO certification audits, and MDSAP assessments, with a strong… more
- Cedars-Sinai (Los Angeles, CA)
- …and patient research billing. This role will comply with all federal, local, FDA , IRB, and HIPAA guidelines and regulations pertaining to the study and patient ... all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board. Maintains research practices using Good… more
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- …Quality, Regulatory and Industry standard requirements. Ensure controls meet BD, FDA , and other applicable regulatory requirements and identifying quality needs, ... years of experience in Supplier Quality in a manufacturing environment working in an FDA or ISO regulated environment + Six Sigma Green Belt and/or Certified (eg… more
- UCLA Health (Los Angeles, CA)
- …and federal guidelines. Key duties include submitting applications to the FDA , IRB, ISPRC, DSMB, ancillary departments, and other applicable review committees ... study protocol and applicable regulations, such as institutional policy and procedures, FDA Code of Federal Regulations (CFR), and ICH Good Clinical Practice (GCP).… 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
- Otsuka America Pharmaceutical Inc. (Palo Alto, CA)
- …development. + **Regulatory Compliance:** + Ensure all engineering activities comply with FDA regulations and ISO 13485 standards. + Prepare and manage documentation ... ultrasonic therapy and renal denervation technologies. + Strong understanding of FDA regulations and ISO 13485 standards. + Excellent leadership, communication, and… more