- J&J Family of Companies (Raritan, NJ)
- …sector) Global Regulatory Affairs (GRA) organization and will support in vitro diagnostics Regulatory Affairs, including companion diagnostics , ... + Oversee the coordination and compilation of global submissions for (new) In Vitro Diagnostics (IVD) and Medical Devices (MD) to Health Authorities (HAs).… more
- Kelly Services (Stillwater, MN)
- …of diagnostic laboratory principles, infectious disease testing, and/or in vitro diagnostics (IVD). + Excellent oral and written communication skills, ... Liaison (MSL)** for a **direct-hire (permanent)** opportunity with one of our innovative diagnostics partners. This position offers the opportunity to serve as a key… more
- Roche (Indianapolis, IN)
- …Expertise:** Valuable experience includes prior knowledge and experience with in vitro diagnostics (IVDs) in industry, R&D, healthcare/clinical laboratory ... **The Position** **Scientific Strategy Director (Infectious Disease - Molecular Diagnostics )** **The Opportunity:** The Scientific Strategy Director holds a critical… 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 ... in oncology precision medicine development and / or in vitro diagnostics development + Experience in companion...development and knowledge of regulatory submission requirements of in vitro diagnostic devices in multiple markets preferred… more
- Caris Life Sciences (Tempe, AZ)
- …a key contributor in the Translational Science team responsible for supporting companion diagnostic and in vitro diagnostic product development lifecycle ... Good Clinical Practices for clinical performance studies. The Global Companion Diagnostics Specialist will collaborate with Clinical Research, QA, Regulatory Affairs… 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
- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- …a healthy work life balance. Description: A world leader in the field of in vitro diagnostics for over 60 years, bioMer ieux provides diagnostic solutions ... which determine the source of disease and contamination to improve patient health and ensure consumer safety. Come be a part of our team and our mission as a Software Project Manager! bioMerieux - Salt Lake City is hiring a Software Project Manager to lead a… more
- Abbott (San Diego, CA)
- …Work On** + Serve as the clinical trial subject matter expert for rapid in vitro diagnostic studies, with a focus on 510(k) OTC and dual 510(k)/CLIA waiver ... the clinical trial subject matter expert for rapid in vitro diagnostic studies, with a focus on...+ years of experience with IRB submissions for In vitro diagnostics and regulatory submission pathways for… more
- LGC Group (Milford, MA)
- …entities include Maine Standards Company, SeraCare Life Sciences, and Technopath Clinical Diagnostics , which are in vitro diagnostics (IVD) manufacturers ... Company Description LGC Clinical Diagnostics develops and manufactures a comprehensive portfolio of catalogue and custom-developed diagnostic quality solutions… 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
- LGC Group (Cumberland Foreside, ME)
- …entities include Maine Standards Company, SeraCare Life Sciences, and Technopath Clinical Diagnostics , which are in vitro diagnostics (IVD) manufacturers ... Company Description ABOUT LGC CLINICAL DIAGNOSTICS : LGC Clinical Diagnostics develops and...and manufactures a comprehensive portfolio of catalogue and custom-developed diagnostic quality solutions and component materials for the extended… more
- IQVIA (Parsippany, NJ)
- …focused on delivering tailored solutions to the **medical device and in vitro diagnostics (IVD) industries** . The **MedTech Mid-Market Account Manager** ... development** and **strategic account expansion** across a defined **portfolio of In Vitro Diagnostics (IVD) clients - including Diabetic Care, Oncology-related… more
- Abbott (Abbott Park, IL)
- …The candidate must possess technical proficiency and experience in the area of in vitro diagnostics design development with a working knowledge of the associated ... corporate liaison and technical expert primarily to the Abbott in vitro diagnostics businesses, developing and providing a strategic framework through the… more
- Roche (Indianapolis, IN)
- …In more than 100 countries, we offer the industry's most comprehensive in vitro diagnostics solutions, covering molecular diagnostics , clinical chemistry and ... people we love. That's what makes us Roche. Roche Diagnostics is a division of Roche. We develop and...is a division of Roche. We develop and integrate diagnostic solutions that address the challenges of today and… more
- Roche (Indianapolis, IN)
- …+ Headquartered in Indianapolis, IN with over 4500 employees + \#1 market leader for in- vitro diagnostics + Working Mothers 100 Best Companies and 50 Best Places ... administrative operations for the following business areas: Diabetes Care, Professional Diagnostics , Molecular Diagnostics , Tissue Diagnostics , Centralized … 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 ... support the global commercialization of new or modified in vitro diagnostic (IVD) devices as well as...work experience. + 7+ years in the medical device, diagnostics , biologics, or pharmaceutical industry, with a focus on… 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 ... the EU Medical Device Regulation (MDR - Regulation (EU) 2017/745) and/or the In Vitro Diagnostic Medical Device Regulation (IVDR - Regulation (EU) 2017/746) +… 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 ... At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop… more
- Roche (Indianapolis, IN)
- …: Valuable experience includes prior knowledge and experience with in vitro diagnostics (IVDs) and/or pharmaceuticals in industry, R&D, healthcare/clinical ... understand medical needs and enable evidence-based use of Roche Diagnostics solutions, ultimately ensuring the right patients have access...at the right time. This role focuses on bringing diagnostic and health solutions to patients in the US,… more