- 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
- Bristol Myers Squibb (Cambridge, MA)
- …Brand, and Translational Medicine teams for which companion, or other in vitro diagnostic development is within strategy. + Responsible for developing ... the Solid Tumor Oncology Diagnostic Sciences strategy for in vitro diagnostic (IVD) programs for immunohistochemistry, Immunoassay, PCR and NGS (tissue and… 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
- 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
- Kelly Services (New York, NY)
- …guide a study team regarding all operational activities for new and/or on-going in vitro diagnostic clinical evaluations. This position is part of the Clinical ... similar). + Minimum of 5 to 8 years of experience with monitoring In Vitro Diagnostic (IVD) products or medical devices. + Experience in all aspects of a… more
- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- …CFR 820 required. 3. Knowledge of quality principles and regulations applicable to in vitro diagnostic products, including FDA QSR, ISO 13485, CMDR, CE Marking, ... ISO 9001, ISO 14971, In Vitro Diagnostic Directive/In Vitro Diagnostic Regulation.4. Knowledge of MDSAP audit program a plus. Experience1. Minimum 5… more
- Randstad US (St. Louis, MO)
- …registrations, listing, and regulatory compliance, with particular focus on In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR; maintaining compliance with ... knowledge of market, competitors, and authority landscape + Experience with in- vitro diagnostics + Advanced written, oral, and interpersonal communication skills… 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
- Kelly Services (Sunnyvale, CA)
- …and completion of specific projects within a **medical device and/or molecular in- vitro diagnostic company** with the objective to deliver projects/programs on ... engineering, or related fields **Preferred Qualifications:** + Medical device and/or In Vitro Diagnostic experience + Experience in Quality System Regulations… more
- Sanofi Group (Cambridge, MA)
- …technology development, and operationalize strategy. Key areas include IV at home, in- vitro diagnostic devices, and targeted non-systemic delivery systems for ... programs and position us for the future, including new areas such as In- vitro diagnostics, IV at home, and targeted delivery systems for Gene therapy. The… more
- Abbott (Princeton, NJ)
- …publications. + Understanding of the clinical laboratory, assay/instrument principles involving in vitro diagnostic product design and usage, and the scientific, ... Abbott Point of Care is a global leader in providing critical medical diagnostic and data management products for rapid blood analysis that are intuitive, reliable,… more
- Danaher Corporation (Sunnyvale, CA)
- …The essential requirements of the job include: + Experience with in vitro diagnostic (IVD) products, preferably in molecular diagnostics or immunodiagnostics, ... 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 (Bothell, WA)
- …of synthetic oligonucleotides under a cGMP environment for use in Cepheid in- vitro diagnostic products. The Laboratory Technician will use scientific knowledge ... 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)
- …+ Masters or Advanced degree strongly preferred + Medical device and/or In Vitro Diagnostic product experience Cepheid, a Danaher operating company, offers a ... 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 (Lodi, CA)
- …This position is part of the Manufacturing Operations group supporting a 24x7 in vitro diagnostic (IVD) manufacturing operation located in Lodi, CA. The schedule ... 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
- Abbott (Scarborough, ME)
- …+ Complies with US Food and Drug Administration (FDA) regulations, In vitro Diagnostic Regulation (IVDR), other regulatory requirements, Company policies, ... exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of… more
- GRAIL (Durham, NC)
- …+ 10+ years experience in any of the following industries: direct In Vitro Diagnostic , medical device or pharma industry. + Experience supporting regulatory ... and to support Grail's partnerships with pharmaceutical companies for companion diagnostic (CDx) tests. The Associate Director will work cross-functionally to manage… more
- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- …and Proficiency testing materials and protocols for bioMerieux molecular in vitro diagnostic tests.4. Primary responsibility involves hands-on testing of ... and molecular biology principles, tools, and techniques relevant to developing diagnostic tests for infectious diseases. * Comfortable working in a dynamic… more
- Amazon (Sunnyvale, CA)
- …qualifications) - . Experienced in regulatory submissions for Medical Devices, In Vitro Diagnostic Devices, Pharmaceutical and/or Biologics. - . Experience of ... working within the requirements of 21 CFR 820, ISO13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC). - . 5-7 years' experience in a regulated industry with experience working with Class II and/or Class III devices. - .… more
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