- 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
- 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
- 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
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