- 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
- 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
- Kelly Services (Washington, DC)
- …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
- Pfizer (South San Francisco, CA)
- …Quality Management Systems (ISO 13485), risk management (ISO 14971), In Vitro Diagnostic Directive Regulation (IVDR), Clinical Laboratory Improvement Amendments ... 820, ISO 13485, IEC 62366, IEC 62304, ISO 14971, In Vitro Diagnostic Directive Regulation (IVDR), ISO 61010, Clinical Laboratory Improvement Amendments (CLIA)… 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
- 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 (Washington, DC)
- …disease/health is preferred. Experience with reimbursement for medical devices, particularly in vitro diagnostic (IVD) laboratory tests is preferred. + The ... 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)
- …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 (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
- Abbott (South Portland, ME)
- …implementation, and monitoring of global clinical studies of new and modified in vitro diagnostic products and ensure that the clinical studies are designed ... responsibility. + Remain current with regulations and clinical requirements for diagnostic products and translate the regulatory requirements into clinical study… more
- BioFire Diagnostics, LLC. (San Jose, CA)
- …the studies performed meet all necessary regulatory and quality standards for in vitro diagnostic (IVD) products. Candidates with a strong background in ... relevant experience in Microbiology, Biochemistry or equivalent and/ or Medical Diagnostic development experience is desired. + Experience working within a… more
- Abbott (Alameda, CA)
- …they meet all medical, legal, and regulatory requirements for medical devices/in vitro diagnostic devices (IVDs) following the established creative design format ... RNA, and proteins at the molecular level. Our Point of Care diagnostic portfolio spans key heath and therapeutic areas, including infections disease,… more
- GRAIL (Menlo Park, CA)
- …+ 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
- Danaher Corporation (Dallas, TX)
- …: + Bachelor's Degree in field with 9+ years of experience in Medical Device, In- Vitro Diagnostic , or a related field, 7+ years of experience with Master's ... we are working at the pace of change to improve patient lives with diagnostic tools that address the world's biggest health challenges. The Clinical Affairs Manager… more
- ThermoFisher Scientific (Middletown, VA)
- …- 1:30am **Location/ Division Specific Information** The Middletown site manufactures in vitro diagnostic reagents, controls and calibrators, which are used in ... conjunction with clinical diagnostic instrumentation. **What will you do?** + Establishing organizational structures and policies that are uniformly deployed across… more
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