- WuXi AppTec (San Diego, CA)
- …Biosciences, Inc. (San Diego), a WuXi AppTec Company, is expanding its In Vitro Immunology team. We're seeking a highly skilled and motivated Research Associate II ... to support our team for cell line generation, and cell-based assays for various projects. **Responsibilities** * Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required. * Normally receives… more
- Actalent (San Diego, CA)
- …for overseeing the labeling process for both new and existing in vitro diagnostic (IVD) and medical device (MD) products. This role requires cross-functional ... collaboration to ensure labeling deliverables meet regulatory, design, and operational standards. Key Responsibilities: + Manage the development and revision of product labeling, including manuals, Instructions for Use (IFUs), packaging, and labels. +… more
- Abbott (Santa Clara, 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). + Effectively communicate verbally and in writing, prepare, and negotiate both internally and externally with various regulatory… more
- Gilead Sciences, Inc. (Foster City, CA)
- …The Research Oncology department at Gilead Sciences (Foster City, CA) is seeking a talented and highly motivated Senior Associate Scientist to join IO/Oncology group. ... The successful candidate is expected to contribute to the discovery, research, and development of novel therapeutic agents to address unmet medical needs of cancer patients. + Independently plan, execute, analyze, troubleshoot, and interpret _in vitro_ and… more
- Merck (South San Francisco, CA)
- …for leading a team of scientists focused on Hit Finding in vitro characterization of antibody candidates across multiple Therapeutic Areas and biologics modalities ... using state-of-the-art methods and lab automation. As the head of a team responsible for delivering high quality characterization data to advance therapeutic programs from de novo discovery into lead candidate selection, this individual will be responsible for… more
- GRAIL (Menlo Park, CA)
- …successful trial initiation and execution + Industry experience within in vitro diagnostics (IVD) highly preferred; pharmaceutical, biologics or medical device ... experience also acceptable + Thorough knowledge of GCP, ICH guidelines and other US and international clinical regulatory requirements + Working experience with an electronic data capture system, CTMS system, and eTMF system. + Experience working on… 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 The essential requirements of the job include: + Bachelor's degree in field with 2+ years of related work experience or master's degree with 1+ years of related work… more
- Zoological Society of San Diego (Escondido, CA)
- …includes semen/sperm evaluation, gamete and gonadal tissue cryopreservation, in vitro oocyte maturation and fertilization, embryo culture, and media preparation. ... Experience with these lab techniques is ideal. Familiarity with hormone assays (RIA and/or ELISA) is advantageous. The team is specifically looking for candidates with experience conducting reproductive research in threatened and endangered species. This… 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
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …years of directly related Regulatory Affairs experience in medical devices and/or in vitro diagnostic field + Minimum of 7 years of personnel management (direct ... report) experience including performance evaluations/improvement, and career development + Software experience including SaMD/SiMD is a plus + Regulatory and Quality Information Management systems such as SAP, RIM, or related systems + Digital literacy MS… more