- Fujifilm (Salt Lake City, UT)
- …that community. As assigned interface with Senior Management teams from major IVD manufacturers. Maintain a comprehensive understanding of IVD reagent systems, ... with healthcare professionals and key opinion leaders for expansion of the IVD portfolio. + Display strong collaboration and teamwork skills with internal and… more
- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- …Fields) with 6 years of experience in a regulated medical device/ IVD industry employment position such as post-market surveillance, quality assurance, regulatory ... Scientific Fields) with 4years of experience in a regulated medical device/ IVD industry employment position such as post-market surveillance, quality assurance,… more
- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- …assessing regulatory risks for products (for both registration and change), driving IVD (as well as RUO and Industry) products through government/regulatory approval ... Science background is preferred. 3+ years in regulatory affairs required, medical device/ IVD industry preferred. Knowledge, Skills and Abilities: + Knowledge of MD/… more
- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- …Testing environments and relevant professional societies and guidelines ( eg FDA, CE-Mark IVD Directives, CAP, CLIA, WHO, IASLC, ASCCP, etc.) Proven track record of ... writing clinical study plans and study protocols Knowledge, Skills & Abilities + Strong computer skills including word processing and use of spreadsheets . Skills with database and project management software desirable. + Demonstrate ability to work… more
- Intermountain Health (Murray, UT)
- …+ Knowledge of validations of Lab Developed Tests and verifications of IVD assays. + ASCP or equivalent certification **Physical Requirements:** + Ongoing need ... for employee to see and read information, labels, documents, monitors, identify equipment and supplies, and be able to assess customer needs. + Frequent interactions with providers, colleagues, customers, patients/clients and visitors that require employee to… more
- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- …and diagnostics products. Responsibilities include conducting testing of reagents and IVD materials as well as personnel swabs. Responsibilities include working with ... the Manufacturing, Technology Transfer and other departments for data collections and validations for new product QC qualifications, organization of quality controlled materials used for QC testing, learning new techniques or workflow as required by new… more
- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- …and diagnostics products. Responsibilities include conducting testing of reagents and IVD materials as well as personnel swabs. Responsibilities include working with ... the Manufacturing, Technology Transfer and other departments for data collections and validations for new product QC qualifications, organization of quality-controlled materials used for QC testing, learning new techniques or workflow as required by new… more
- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- …required. Science background is preferred. Specialist: 3+ years in regulatory affairs, medical device/ IVD industry required. 3+ years in FDA environment preferred. ... The Regulatory Affairs position within Regulatory Policy & Intelligence (RP&I) is responsible for contributing to or leading impact assessments and for changes to regulatory requirements, assessing applicability regarding regulatory submissions and procedures,… more