- AbbVie (Chicago, IL)
- …Facebook, Instagram, YouTube and LinkedIn. Job Description The Manager, Regulatory Affairs In Vitro Diagnostics and Companion Diagnostics works with internal ... and external partners to develop and implement global regulatory strategies for In Vitro Diagnostics (IVD)/Companion Diagnostics (CDx) to support business… more
- Danaher Corporation (Washington, DC)
- …of pharma (from Research Use Only (RUO) to Clinical Trial Assay (CTA) to In Vitro Diagnostics (IVD) inclusive of Companion Diagnostics (CDx) and Lab ... solutions through organic and inorganic efforts in all aspects of neurological diagnostic applications. Reporting to the CSO, Danaher Diagnostics , this position… more
- BioFire Diagnostics, LLC. (San Jose, CA)
- …preference for candidates who have worked in R&D in product development roles on in vitro diagnostics and biosensors. For candidates with a MS degree must have ... an R&D environment in product development roles in the field of in vitro diagnostics and biosensors. Must have a proven track record of conducting independent… more
- Mayo Clinic (Rochester, MN)
- …support research and development teams within the pharmaceutical, biotech, and in vitro diagnostics industries and their collaborators. This includes laboratory ... Mayo Clinic entity that offers a full range of laboratory testing, diagnostic services and support products to health care providers/institutions and the biopharma… 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
- Actalent (Omaha, NE)
- Description: This lab tech will be working in the micro diagnostic lab. This lab is the first place where they receive all of the samples from the farmer. These ... for autogenous seed. * Prepare and store autogenous bacterial seeds. * Perform in- vitro antibiotic sensitivity testing. * Prepare and Gram stain slides of various… 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
- 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 ... Knowledge/experience regarding US regulatory guidelines associated with the use molecular diagnostics is desired. Familiar with a variety of the field's concepts… more
- Actalent (Louisville, CO)
- …realization (test specimen receipt through test result generation) using standard in- vitro laboratory techniques in Molecular Biology (PCR) and in Mass Spectrometry. ... Our focus areas of test development include oncology and virology. This experienced candidate is comfortable with SOPs and Work Instructions, working with data, standard laboratory chemicals, human blood specimens and is versed in standard molecular biology… more
- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- …a team that supports the analytical studies for regulatory submissions of in vitro diagnostic (IVD) products developed by bioMerieux. The primary responsibility ... regulatory requirements, guidelines, and expectations for establishing performance of diagnostic products and maintains broad knowledge of state-of-the-art principles… more
- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- …DNA and RNA template control components to support the company's in vitro diagnostic products' research and development, manufacturing, validations, and quality ... control efforts. The LT-I will use established methods and techniques to maintain the lab's DNA and RNA template inventory, perform template manipulations and verification including diluting, aliquoting, mixing, quantitative PCR, quantitative RT-PCR, and… more
- New York University (New York, NY)
- …extensive experiences in the areas of microfluidics-based point-of-care devices, in vitro diagnostics , ELISA-based assays, and biosensors. The selected ... p24 and Env for use in newly fashioned in vitro diagnostic devices + Use principles of...field + Industrial experience in point-of-care testing and in vitro diagnostics although not required can be… 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 ... Leica Biosystems' mission of "Advancing Cancer Diagnostics , Improving Lives" is at the heart of...experience in leadership positions in medical device or in- vitro diagnostic industry. + Successful track record… more
- Danaher Corporation (Chaska, MN)
- … Diagnostics plays a crucial role in obtaining clinical samples for in vitro diagnostics and managing the inventory associated with these samples. This ... the pace of change to improve patient lives with diagnostic tools that address the world's biggest health challenges....+ Oversee the acquisition of clinical samples for in vitro diagnostics , ensuring adherence to ethical and… more
- Kelly Services (Washington, DC)
- …also possess previous experience in:** + Experience with in vitro diagnostic (IVD) products in molecular diagnostics or immunodiagnostics especially in the ... study team regarding all operational activities for new and/or on-going in vitro diagnostic clinical evaluations. This position is part of the Clinical Affairs… more
- ThermoFisher Scientific (San Jose, CA)
- …(R&D) team. The ideal candidate will have a strong background in In Vitro Diagnostics Regulation (IVDR) and experience in scientific research and product ... compliance, scientific research, and product development within the field of in vitro diagnostics . + **Hands-on experience with liquid chromatography and mass… more
- Abbott (Alameda, CA)
- …of Quality Systems, Quality Assurance and/or Regulatory Compliance/Affairs experience in In Vitro Diagnostics and medical device manufacturing or other similarly ... the spectrum of healthcare, with leading businesses and products in diagnostics , medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more
- Bio-Techne (San Marcos, CA)
- …Bio-Techne, San Marcos you'll join a proven leader in the Manufacturing of In- Vitro Diagnostics . Our Research Associates are focused on the product development ... of diagnostic assays, to include reagents, calibrators, controls, calibration verifiers...field preferred with 0-2 years work experience in In Vitro diagnostics , medical device, pharmaceutical or related… more
- Danaher Corporation (Chaska, MN)
- …+ Demonstrated knowledge and understanding of global regulations and guidelines governing in- vitro diagnostics . + RAC certificate + IVDR regulations knowledge At ... the support you need to be successful. Beckman Coulter Diagnostics is proud to work alongside a community of...the pace of change to improve patient lives with diagnostic tools that address the world's biggest health challenges!… more
- Danaher Corporation (Chaska, MN)
- …the life sciences or related field required with 5+ years' experience in vitro diagnostics (IVD), Medical Device, or Healthcare clinical field, Master's degree ... the support you need to be successful. Beckman Coulter Diagnostics is proud to work alongside a community of...the pace of change to improve patient lives with diagnostic tools that address the world's biggest health challenges.… more
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