- ThermoFisher Scientific (Carlsbad, CA)
- …Chemistry, bio-engineering or related science. **Experience** + 3+ years experience in the In Vitro Diagnostic , Medical Device Industry or similar. + 3+ years of ... on ensuring that both internal and external projects for advancing our in vitro diagnostics adhere to Good Clinical Practice (GCP) and relevant regulatory standards… more
- Hologic (San Diego, CA)
- …Create and maintain the Diagnostics global post market documentation for EU In Vitro Diagnostic Medical Device Regulation (IVDR) PMS Reports (PMSR), Periodic ... science, engineering, or a healthcare-related field + Knowledge of regulations for In- Vitro Diagnostic Regulation (2017/746) and Health Canada regulations is… more
- Danaher Corporation (West Sacramento, CA)
- …part of a multifunctional team and drive to root cause for manufacturing of in- vitro diagnostic consumables. + Lead projects to assess risk (pFMEAs), perform ... validations (equipment, process, software), and implement process changes for manufacturing of in- vitro diagnostic consumables. + Lead or participate in cross… more
- Danaher Corporation (Sunnyvale, CA)
- …and completion of Operations programs within a medical device and/or molecular in- vitro diagnostic company while ensuring consistency with company strategy, ... or DBS certification is highly preferred. + Medical device and/or In Vitro Diagnostic product experience. + Business solutions implementation experience.… more
- Kelly Services (Sunnyvale, CA)
- …and overseeing the translation of customer-facing documents for our client's in vitro diagnostic tests and instrument systems. Document types include ... guidelines, and regulations governing the development, documentation, and labeling of in vitro diagnostic products. + Strong verbal communication skills for… more
- Danaher Corporation (Sunnyvale, CA)
- …and/or Human Physiology with related work experience. + Experience with in vitro diagnostic (IVD) products, preferably in molecular diagnostics or ... are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of...Together, we're working at the pace of change on diagnostic tools that address the world's biggest health challenges,… more
- Danaher Corporation (Sunnyvale, CA)
- …compliance with Food & Drug Administration (FDA), ISO 13485, European Union In Vitro Diagnostic Regulation (IVDR) as well as other applicable global regulatory ... are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of...Together, we're working at the pace of change on diagnostic tools that address the world's biggest health challenges,… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …related Regulatory and Regulatory Operations experience in medical devices and/or in vitro diagnostic field + Experience in Regulatory and Quality Information ... Management systems such as SAP, RIM, Veeva, Sharepoint or related systems + Working experience on creating dashboards and data analysis using tools like power BI. Knowledge and Skills + Working knowledge Regulatory Systems implementation + Ability to manage… more
- AbbVie (Irvine, CA)
- …Demonstrated success in directly securing regulatory clearance/approvals for In vitro diagnostic products required, device regulatory product strategies, ... and identifies data and information requirements. Seeks expert advice and technical support as required for strategies and submissions. Makes decisions and provides guidance for support of medical device and combination products. + Manages the preparation and… more
- Bio-Techne (San Jose, CA)
- …Experience in biotechnology new product development for research use only (RUO) or in- vitro diagnostic (IVD) is required + Experience with biomolecule analytical ... separation and detection methods eg, HPLC, capillary electrophoresis (CZE, cIEF, CE-SDS), microfluidics is required + Must have demonstrated ability to develop commercial products of high degree of complexity + Strong track record of technical leadership,… more