- GRAIL (Durham, NC)
- …GRAIL's quality management system (QMS). This role's focus is on the in vitro diagnostic medical device processes, supporting the clinical laboratory processes ... pharmaceutical, or biotech quality management system. + Experience working with in vitro diagnostic medical device regulations and standards including ISO… more
- GRAIL (Menlo Park, CA)
- …This individual monitors and communicates changes in regulatory policies and In Vitro Diagnostic (IVD) requirements to project teams and leadership. They ... may manage and provide direction to regulatory staff and, when required, participate in senior management meetings as a delegate. The role fosters a work culture aligned with GRAIL's values **Responsibilities:** + Strategize, plan, and author regulatory plans… more
- Amgen (Washington, DC)
- …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
- Danaher Corporation (Minneapolis, MN)
- …experience. + In depth understanding of ISO 14155, 13485, 14971, 20916, in vitro diagnostic regulation (IVDR), medical device regulation (MDR), and pertinent ... or ASQ CBA, GCP) + The technology and assays related to in vitro Diagnostic (IVD) across one or more of the following areas: chemistry, immunoassay, hematology,… more
- Sanofi Group (Cambridge, MA)
- …diverse team supporting the medical device, combination product, digital health and in- vitro diagnostic (IVD) products within the Sanofi portfolio of products. ... Diagnostic team you'll contribute to global regulatory strategies for in- vitro diagnostic technologies, collaborate with cross-functional teams to navigate… more
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- …regulatory submissions to support the global commercialization of new or modified in vitro diagnostic (IVD) devices. The ideal candidate will have strong ... submissions to support the global commercialization of new or modified in vitro diagnostic (IVD) devices as well as research use only (RUO) products. The… more
- Actalent (San Diego, CA)
- …+ Previous experience within a regulated medical device manufacturing or In- Vitro Diagnostic Device environment. + Previous Quality Assurance experience ... of Microsoft Office programs. Additional Skills & Qualifications + Med device/ diagnostic experience is ideal. + Strong leadership and communication skills. +… more
- Abbott (Pomona, CA)
- …will lead cross-functional teams in the development and commercialization of In Vitro Diagnostic (IVD) products within Abbott's Toxicology business unit. This ... a team player who possess effective communication + Hands-on experience with in- vitro diagnostic + Medical device development and product commercialization… more
- Abbott (Alameda, CA)
- …vocational qualifications) + Experienced in regulatory submissions for Pharmaceutical, in vitro diagnostic devices and/or medical devices. + Experience of ... Device Regulation (MDR - Regulation (EU) 2017/745) and/or the In Vitro Diagnostic Medical Device Regulation (IVDR - Regulation (EU) 2017/746) + Experience… more
- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- …II position supports the performance assessment and validation of molecular in vitro diagnostic products within the Clinical Affairs Lab Operations team. ... goals. Responsible for creating, optimizing ,developing, updating and sustaining diagnostic assays and reagents in a regulated environment, while driving… more
- Kelly Services (Chaska, MN)
- …Sciences + Subject matter expertise in registration and commercialization of in vitro diagnostic medical devices + Demonstrated experience leading design change ... + Demonstrated knowledge and understanding of regulations and guidelines governing in- vitro diagnostics. + Strong Health Canada, and EU submission experience… more
- Danaher Corporation (Sunnyvale, CA)
- …compliance with Food & Drug Administration (FDA), ISO 13485, European Union In Vitro Diagnostic Regulation (IVDR) as well as other applicable global regulatory ... 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 (Princeton, NJ)
- …industry. + 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,… more
- ThermoFisher Scientific (Phoenix, AZ)
- …ISO 13485) preferred. + Working knowledge of FDA regulations and IVDR (In Vitro Diagnostic Regulation) requirements is highly preferred. + Familiarity with HLA ... a growing software organization, you will work at the intersection of diagnostic precision, digital health, and lab workflow transformation. You will contribute to… more
- Sanofi Group (Morristown, NJ)
- …diverse team supporting the medical device, combination product, digital health and in- vitro diagnostic (IVD) products within the Sanofi portfolio of products. ... GRA Device Lead in the GRA Device Digital and Diagnostic team you'll drive global regulatory strategies for medical...enhanced through our diverse portfolio of medical device and diagnostic products. Together, we chase the miracles of science… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …perform hands-on laboratory work **Preferred Qualifications:** + Experience in IVD (In Vitro Diagnostic ) product development + Knowledge of leukemia, lymphoma, ... 5 years of experience in a clinical research setting, clinical/ diagnostic laboratory, or pharmaceutical/biotechnology R&D environment + Demonstrated expertise in… more
- Danaher Corporation (Richmond, IL)
- …Biosystems is responsible for working with cross-functional teams to bring IVD (In- Vitro Diagnostic ), Research (RUO) and Laboratorial products to market and ... knows every moment matters when it comes to cancer. You'll help develop diagnostic solutions that turn anxiety into answers, and aid the acceleration of… more
- Adecco US, Inc. (Middletown, VA)
- …and Holiday pay upon meeting eligibility criteria The Middletown site manufactures in vitro diagnostic reagents, controls and calibrators, which are used in ... conjunction with clinical diagnostic instrumentation. Position Summary: Senior Formulation role Manufactures buffers and simple bulk reagents per manufacturing… more
- Adecco US, Inc. (Middletown, VA)
- …VA How will you make an impact: The Middletown site manufactures in vitro diagnostic reagents, controls and calibrators, which are used in conjunction ... with clinical diagnostic instrumentation. What will you do? Colleagues will operate, maintain & troubleshoot all production equipment associated within the… more
- Roche (Branchburg, NJ)
- …site in North America, our teams deliver a broad portfolio of PCR-based in- vitro diagnostic tests. Our operations include reagent and active diagnostic ... ingredient (ADI) production, filling and packaging. Our 63-acre site with ~1400 people is currently under expansion, fueled by our culture of agility, innovation and transformation. Each day we focus on delivering the value of Roche Diagnostics to patients… more
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