- Abbott (Alameda, CA)
- …action of medical devices, including software as a medical device (SaMD), in- vitro , diagnostic devices, consumer devices, and accessories. **What You'll Work On** + ... Lead/support design planning efforts to include heading cross-functional teams; establishing deliverables and tracking completion for complex projects + Lead/support complex investigations and CAPA activities + Drives alignment in cross functional meetings… more
- Abbott (Alameda, CA)
- …vocational qualifications) . Experienced in regulatory submissions for Pharmaceutical, in vitro diagnostic devices and/or medical devices. . Experience of working ... within the requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC). Preferred Qualifications . 5 years' experience working with Class II, Class III medical devices and/or biologics/drugs. Regulatory… more
- Cedars-Sinai (CA)
- …induced pluripotent stem cells (hiPSCs) to model cardiovascular diseases in vitro . The lab utilizes cutting-edge technologies, including hiPSCs, CRISPR/Cas9 genome ... editing, cardiac microfluidic organ-chips and cardiac organoids in our studies. Specifically, we have used hiPSC-derived cardiomyocytes (heart muscle cells) to model cardiac viral infections during COVID-19, examine developmental mechanisms underlying… more
- Gilead Sciences, Inc. (Foster City, CA)
- …**Scientist, Inflammation** The Inflammation Biology group at Gilead Sciences is seeking a highly motivated Scientist to join our collaborative and interdisciplinary ... research team. The successful candidate will be responsible for supporting novel target identification and drug development to address clinical unmet need in inflammatory and autoimmune diseases. As a member of cross-functional teams, the candidate will use… more
- Danaher Corporation (Sunnyvale, CA)
- …with Food & Drug Administration (FDA), ISO 13485, European Union In Vitro Diagnostic Regulation (IVDR) as well as other applicable global regulatory requirements, ... including Medical Device Single Audit Program (MDSAP) participating regulatory authorities + Provide cross-functional compliance support for global QMS and Intracompany Quality Agreement requirements. Function as SME for compliance related topics, including… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …for PK and PK/PD activities related to formulation development, in vivo-in vitro correlations and biowaivers for pre- and post-approval formulations. + Manage ... **pharmacometrics** activities related to project budgets, outsourcing of PK and PK/PD analyses, contract requisition, SOW and approval of invoices. + Interact with clinical pharmacology to support **PBPK** , **population PK and PK/PD modeling** + Serve as… more
- GRAIL (Menlo Park, CA)
- …This individual monitors and communicates changes in regulatory policies and In Vitro Diagnostic (IVD) requirements to project teams and leadership. They may manage ... and provide direction to regulatory staff and, when required, participate in senior management meetings as a delegate. The role fosters a work culture aligned with GRAIL's values **Responsibilities:** + Strategize, plan, and author regulatory plans and… more
- Fujifilm (Sacramento, CA)
- …imaging, enterprise imaging, endoscopic and surgical imaging, as well as in- vitro diagnostics. But we don't stop at healthcare; our Non-Destructive Testing ... (NDT) team harnesses advanced radiography solutions to keep transportation infrastructure, aerospace, and oil and gas assets safe and running smoothly. Ready to innovate, collaborate, and make a difference? Join us and bring your big ideas to life while… more
- Dignity Health (Oxnard, CA)
- …Demonstrates knowledge of Nuclear Medicine procedures in vivo and in vitro Radiopharmacy-dose calibration and calculations bio-routing of labeled products computers ... and some computer processing. + Excellent written/verbal communication skills and the ability to work with a wide range of individuals. + Ability to work independently and be a functional team member in a team oriented environment. + Self-motivated and able to… more
- Fujifilm (Sacramento, CA)
- …imaging, enterprise imaging, endoscopic and surgical imaging, as well as in- vitro diagnostics. But we don't stop at healthcare; our Non-Destructive Testing ... (NDT) team harnesses advanced radiography solutions to keep transportation infrastructure, aerospace, and oil and gas assets safe and running smoothly. Ready to innovate, collaborate, and make a difference? Join us and bring your big ideas to life while… more