- Lilly (Indianapolis, IN)
- …Associate Director, Diagnostic Development will serve as the investigational in vitro diagnostic ( diagnostic ) trial-level expert for global clinical ... scientists, and clinical operations to solve sophisticated, outstanding, and specialized diagnostic implementation issues + Manage the relationship and serve as the… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …team in further launch activities. The ideal candidate will have medical device and in vitro diagnostic experience in the US and EU, as well as experience with ... Minimum 5 years Regulatory Affairs experience in medical device or in vitro diagnostic device companies or an equivalent combination of experience with an… more
- 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
- Bristol Myers Squibb (Cambridge, MA)
- …Experience with or good working knowledge of a broad range of biomarker/in vitro diagnostic platforms. Demonstrated matrix leadership skills and the ability to ... Medicine Search, Evaluation, and Alliances is responsible for leading strategic diagnostic initiatives that support BMS's Precision Medicine strategy. This includes… 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
- Actalent (Boston, MA)
- …alongside a multidisciplinary development project team, responsible for ensuring that the in vitro diagnostic system meets its intended goals. The person in this ... role can develop, optimize, and validate assays for an in- vitro diagnostic system. This role will support the development project team by designing and building… 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
- Kelly Services (Boston, MA)
- …As a Scientist, you will be developing, optimizing, and validating assays for in- vitro diagnostic systems. You will be designing and building prototype assays, ... handling biological samples and chemicals. + Previous experience and knowledge of in vitro diagnostics assays is strongly preferred. As part of our promise to… more