- Merck & Co. (North Wales, PA)
- …relevant regulatory experience.Required Experience and Skills:- Diagnostics/In Vitro Diagnostics. Experience in Oncology/non-oncology companion/complementary ... to the world by facilitating effective, efficient, and compliant drug/ diagnostic regulatory strategies and approaches across geographies.Under direction of the… more
- Merck & Co. (Rahway, NJ)
- …management and strategic marketing experience in oncology within pharma and/or in vitro diagnostics Oncology diagnostic / Precision Medicine product launch ... the Global Asset Leaders and Global Business Leaders in Human Health (HH), Diagnostic Digital Experts and Diagnostic Development Teams (DxDTs) in our Company's… more
- ICON Clinical Research (Farmingdale, NY)
- …sector, and you'll be helping shape an industry. **Regulatory Affairs Manager - In Vitro Diagnostic (IVD) Medical Devices** **The role:** As a Regulatory Affairs ... Manager you will need to be experienced with In Vitro Diagnostic (IVD) Medical Device and CDx directives, regulation, and regulatory structure (required Economic… more
- New York University (New York, NY)
- …detection of the HIV proteins p24 and Env for use in newly fashioned in vitro diagnostic devices + Use principles of ELISA-based assays for biosensor development ... thinking + ELISA-based or related immune assay experience + In vitro diagnostic experience + Multiplexed detection of biomarkers + Point-of-care devices +… more
- Amgen (Thousand Oaks, CA)
- …a breadth of technical expertise across a broad range of in- vitro diagnostic technologies, influencing decision-making through negotiation, and addressing ... companion diagnostics development and knowledge of regulatory submission requirements of in vitro diagnostic devices in multiple markets preferred + Knowledge… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …will be responsible for planning, conducting and leading clinical audits for in vitro diagnostic medical devices and in vivo medical devices, in accordance ... be responsible for planning, conducting and leading clinical audits for in vitro diagnostic medical devices and in vivo medical devices, in accordance with 21… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …quality, compliance or related experience supporting medicinal products with experience in vitro diagnostic development. + Understanding of global policy, laws, ... clinical research or other related healthcare environment. Experience in in vitro diagnostic development strongly preferred **Knowledge & Other Requirements**… more
- Danaher Corporation (Richmond, IL)
- …years of product management or marketing experience, preferable for medical device or in- vitro diagnostic industry + 5+ years of business and commercial ... experience in leadership positions in medical device or in- vitro diagnostic industry. + Successful track record of commercial success in development of product… more
- ThermoFisher Scientific (Austin, TX)
- …performing cutting edge new product development using Ion Torrent instruments for vitro diagnostic (IVD) applications. You will help provide hardware support ... and help design new tools or tests to improve calibration and diagnostic functionality for NGS instrumentation. Build instrument knowledge and diagnostic … more
- BD (Becton, Dickinson and Company) (Sparks, MD)
- …relationships with regulators. + Knowledge of regulations applying to medical devices and in vitro diagnostic devices including software in the US, and EU. Must ... of directly related regulatory experience in the medical device and/or in vitro diagnostic device area(s) including experience with software as a medical device.… more
