- DivIHN Integration Inc (Lake Forest, IL)
- …RESPONSIBILITIES: Responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR). Provides regulatory support ... for diagnostic product development and commercial diagnostic products. Develops regulatory strategies for products in development and for modified products to… more
- DivIHN Integration Inc (Lake Forest, IL)
- …RESPONSIBILITIES: Responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR). Provides regulatory support ... for diagnostic product development and commercial diagnostic products. Develops regulatory strategies for products in development and for modified products to… more
- DivIHN Integration Inc (Scarborough, ME)
- …RESPONSIBILITIES: Responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR). Provides regulatory support ... for diagnostic product development and commercial diagnostic products. Develops regulatory strategies for products in development and for modified products to… more
- Integrated Resources, Inc (Miami, FL)
- …a combination of clinical laboratory and either clinical research laboratory or in- vitro diagnostic / biotechnology / Pharmacology (FDA regulated) laboratory ... experience * MT or CLS (ASCP) or equivalent certification/license highly preferred * Prior R&D and/or clinical experience in urinalysis, hematology, immunoassay, clinical chemistry, or flow cytometry preferred more
- ProKatchers (St. Louis, MO)
- …registrations, listing, and regulatory compliance, with particular focus on In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR; maintaining compliance with ... requirements of FDA 21 CFR 820, CMDR SOR 98-292, ISO 13485:2016, and other applicable International Medical Device Regulations. more
- George Washington University (Washington, DC)
- …is interested in working in the development and efficacy testing of vaccines, diagnostic tests, and therapeutic drugs against viral diseases. The Watkins' lab has ... -Maintains the lab and laboratory equipment-Performs mammalian cell maintenance in vitro .-Processes animal blood into different components for use in immunological… 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
- Bristol Myers Squibb (Princeton, NJ)
- …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
- 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
- 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
- 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
- ThermoFisher Scientific (Middletown, VA)
- …- 3:30pm **Location/ Division Specific Information** The Middletown site manufactures in vitro diagnostic reagents, controls and calibrators, which are used in ... conjunction with clinical diagnostic instrumentation. **A day in the Life:** + Establishing organizational structures and policies that are uniformly deployed across… more
- ManpowerGroup (Lake Forest, IL)
- …Affairs organization by - + Responsible for technical writing of files by In Vitro Diagnostic Medicaldevice Regulation (IVDR). + Provides regulatory support for ... diagnostic product development and commercialdiagnostic products. + Develop regulatory strategies for products in development and for modified products toachieve… more
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