- 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
- Danaher Corporation (Chicago, IL)
- …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
- Pfizer (South San Francisco, CA)
- …Quality Management Systems (ISO 13485), risk management (ISO 14971), In Vitro Diagnostic Directive Regulation (IVDR), Clinical Laboratory Improvement Amendments ... ISO 13485, IEC 62366, IEC 62304, ISO 14971, In Vitro Diagnostic Directive Regulation (IVDR), ISO 61010,...4, CLIA and the EU Medical Devices and In Vitro Diagnostics Regulation. + Familiarity with EN… 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
- Actalent (Omaha, NE)
- …vaccines for farmers around the country. This lab tech will be working in the micro diagnostic lab. This lab is the first place where they receive all of the samples ... for autogenous seed. * Prepare and store autogenous bacterial seeds. * Perform in- vitro antibiotic sensitivity testing. * Prepare and Gram stain slides of various… more
- ThermoFisher Scientific (Waltham, MA)
- …care journey. With over 40 locations, the SDG divisions focus on in vitro diagnostics including test kits, reagents, culture media, instruments, and associated ... find cures for cancer. **Division Specific Information:** The Specialty Diagnostics Group (SDG) helps Thermo Fisher achieve its Mission… more
- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- A world leader in the field of in vitro diagnostics for over 55 years, bioMerieux provides diagnostic solutions which determine sources of disease and ... team members across 11 sites or subsidiaries, including Salt Lake City-based BioFire Diagnostics . Come and join an amazing global company with a solid long-term… more
- Actalent (Omaha, NE)
- …for autogenous seed. * Prepare and store autogenous bacterial seeds. * Perform in- vitro antibiotic sensitivity testing. * Prepare and Gram stain slides of various ... between warehouse and production areas. * Autoclave infectious materials generated in Diagnostics , PCR, and R&D areas. * Analyze experimental data and interpret… 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