- Merck & Co. (North Wales, PA)
- …Scientist/Director will be responsible for:Providing critical strategic and tactical CDx/ IVD regulatory guidance that positively influences project planning and ... decision making.-Developing regulatory strategies for assigned products (non-oncology/oncology) to enable and/or support timely approval of both therapeutic and diagnostic products by regulatory agencies.Representing the Global CDx Regulatory position and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …working on multidisciplinary pharmaceutical /diagnostic development teams.Understanding of the IVD Development Process, with indirect or direct experience with ... Companion Diagnostics DevelopmentBroad knowledge and understanding of established and new assay technologies such as NGS, IHC, PCR etc.Knowledge of drug development process and an understanding of how diagnostic development can shape drug development and… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …using a data-driven human translational approach. The In Vitro Diagnostic ( IVD ) Regulatory Affairs (RA)Team along with the Regulatory Affairs Global Regulatory ... strategies across its growing clinical portfolio. The Sr. Manager, Regulatory Affairs IVD will work closely with their RA GRS counterparts, the Companion Diagnostics… more
- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- …(non-clinical) studies for regulatory submissions of in vitro diagnostic ( IVD ) products developed by bioMerieux. The Associate Director's primary responsibility ... that support global regulatory submissions and pre/post market support for bioMerieux's IVD products. Please include a cover letter indicating your interest in and… more
- IQVIA (Durham, NC)
- …are accurate Ideal Experience + Candidates with 5-10 years of diagnostic ( IVD ) clinical trial management experience + PHCS/CDx experience is highly preferred as ... well as pathology/tissue diagnostic experience is also preferred + Strong project management and organizational skills, leadership, teamwork/collaboration, stakeholder management, clear communication skills + Experience with global studies and IVDR REQUIRED… more
- Nanobiosym, Inc. (Cambridge, MA)
- …or related field + Minimum of 7 years of relevant industry experience and IVD assay development + In depth knowledge and hands on experience with qPCR, sequencing ... and standard molecular biology techniques + Demonstrated technical, managerial and leadership expertise in assay development + Strong understanding of FDA and global regulatory requirements + Prefer commercial assay experience + Demonstrated experience and… more
- Abbott (Lake Forest, IL)
- …+ BS/BA degree in a science related or technical field or other field with equivalent combination of work experience. + Minimum 10 years progressively work experience ... Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and… more
- Hologic (San Diego, CA)
- …and publish electronic post-market regulatory submissions. + Compile Technical Documentation for IVD medical devices to support EU IVDR CE-Mark and other annual ... CE-Mark requirements. + Interact with business partners to support ROW submissions for IVD medical devices (Asia PAC, Mexico, Brazil, Canada etc.) + Develop and… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …assistance through all stages of clinical development through global registration for IVD projects. In addition, you may be involved in the identification of ... key interactions with Health Authorities. + Maintains current understanding of global IVD /CDx regulations, assesses and communicates their impact on drug and IVD… more
- Caris Life Sciences (Phoenix, AZ)
- …the implementation of manufacturing operations in a hybrid (diagnostic/ IVD and clinical/CLIA/CAP/LDT) laboratory environment. **Job Responsibilities** Process ... such as DHR (Device History Record or batch records) for new medical device/ IVD products. + Coordinate the training of Laboratory Ops personnel, Quality Engineers… more
- Hologic (San Diego, CA)
- …be responsible for testing software for highly complex medical devices/instrumentation for IVD Product Development and IVD Product Testing. **Essential Duties ... in the design, development, and debugging of SW programs; + IVD Product Development and IVD Product Testing. + Molecular diagnostic technology and nucleic acid… more
- ICON Clinical Research (Farmingdale, NY)
- …Affairs Manager you will need to be experienced with In Vitro Diagnostic ( IVD ) Medical Device regulation and Laboratory Developed Tests within the United States ... under FDA. This role will be collaborating with IVD product development teams in the context of early...candidate will have prior experience with Regulatory Affairs for IVD device submissions in the context of drugs/biologics submissions,… more
- BD (Becton, Dickinson and Company) (Sparks, MD)
- …the CPM will: + Lead all aspects of the planning and execution of IVD clinical studies, including study timeline development, to ensure that results are completed on ... desired. **Knowledge and Skills:** + Three (3) or more years of experience with IVD clinical research studies from study planning to study closeout. + One (1) or… more
- ThermoFisher Scientific (Middletown, VA)
- …The Clinical Diagnostics Division (CDD) provides innovative diagnostic solutions for select IVD market segments and has been a trusted supplier in the ... IVD industry for over 40 years. The division provides...of the world's largest suppliers of in vitro diagnostic ( IVD ) products rely on us as their OEM and… more
- Kelly Services (West Hills, CA)
- …for compliance to the non-conformance process, and to applicable Medical Device and IVD regulations and requirements by serving as a subject matter expert in ... with the Quality Managment system, FDA regulations, ISO 13485, and Medical Device and IVD requirements through the review of NC records at critical phases. + Provide… more
- Abbott (Alameda, CA)
- …Specifically in regards with EU medical device and in vitro diagnostic ( IVD ) (EU Regulation 2017/745 and EU Regulation 2017/746) Economic Operators who act ... requirements of ISO 13485 and EU medical device and in vitro diagnostic ( IVD ) (EU Regulation 2017/745 and EU Regulation 2017/746). * Maintain and develop positive… more
- ThermoFisher Scientific (Fremont, CA)
- …chemicals and biologicals to manufacture reagents, calibrators, and controls for IVD immunoassay use and participate in process improvements projects. **What you ... 1+ years of related experience and/or training preferred + IVD immunoassay manufacturing experience is preferred + Experience in...tasks in compliance with GMP, GDP, QSRs, ISO and IVD regulations + Ability to be organized and detail… more
- TE Connectivity (Parker, CO)
- …strategy and road map of delivery for your site in line with the IVD business strategy ensuring alignment throughout the facility to goals and deliverables * Site ... focuses on continuous improvement * Engage with the other IVD Ops managers globally to ensure standardization of process...to ensure standardization of process and approach across the IVD Operations network * Manage and optimize resources to… more
- Danaher Corporation (Chaska, MN)
- …or cell biology and prior experience in the development and commercialization of immunoassay IVD or RUO products, and want to work to build a world-class immunoassay ... also possess previous experience in: + Commercialized RUO or IVD assays + Experience achieving regulatory clearance for ...IVD assays + Experience achieving regulatory clearance for IVD products When you join us, you'll also be… more
- Adecco US, Inc. (Irvine, CA)
- …assay verification and validation with the team + Participates in projects for Biomarker/ IVD assay development in various disease areas. + Ensures quality in work, ... disciplines. + Experience + Minimum 1 year of industry experience in IVD immunodiagnostics fields, or other related diagnostic fields. + Experience with ELISA,… more
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