- Daiichi Sankyo, Inc. (Bernards, NJ)
- …CDx development : Provide critical strategic and tactical regulatory guidance for CDx/ IVD development and CDx submission plan for each country/region, both before ... and after CDx testing, for less complex projects.At the time of implementation of a CDx study/IVDR performance evaluation study integration of an assay into clinical testing (before testing) and once data is ready for CDx submission (after testing)Serve as the… more
- Veracyte (South San Francisco, CA)
- …individual to join the Veracyte R&D Team as a Principal Scientist for IVD product development. This exciting and challenging role is responsible for leading the ... genomics assay workflows, test kit components and controls, and performance of IVD assays, along with overseeing technical team members. To be a successful… more
- EPM Scientific (San Diego, CA)
- …locations Ability to work effectively with cross-functional and risk management teams IVD and CDx experience is preferred Responsibilities of the Manager include: ... Ensure compliance with evolving regulations, including FDA Medical Device Regulations and EU-MDR, by supporting regulatory initiatives Monitor and interpret regulatory changes and international standards for US and global markets, providing insights to… more
- Omni Inclusive (Waltham, MA)
- …help with this growth, we need a Manufacturing Associate and join our IVD manufacturing team and contribute to the component manufacturing for immunoassay kits, ... and the overall operation of lab equipment. About the IVD Manufacturing Team at Abcam: The IVD Manufacturing Team works closely with other teams across the… more
- Danaher (Miami, FL)
- …cytometry reagents portfolio in the research, clinical research and clinical IVD market segments Understand market dynamics and technological innovations. Identify ... engineering, or related field. 3+ years' experience in product management in the IVD or medical devices industry and/or experience in the flow cytometry industry… more
- Bio-Rad Laboratories, Inc. (Pleasanton, CA)
- …research and translational space including clinical trials, global regulatory landscapes for IVD , LDT etc. Ability to develop and articulate business cases based on ... primary and secondary market research, understanding of the technical and scientific needs, and competitive landscape. Proven ability to work with cross-functional teams including strong written, verbal and interpersonal skills with high emotional… more
- Kelly Services (Seattle, WA)
- …new or revised standards, expanded claims, recalls, adverse events, and impact on the IVD product and provide the appropriate data to the Project Lead to prepare ... regulatory bodies is highly preferred. . Experience with US and international IVD regulations . Broad knowledge of post market surveillance regulations, practices,… more
- Danaher Corporation (Marlborough, MA)
- …It would be a plus if you also possess previous experience in: + IVD and Proteomics Platforms + Working with US pharmaceutical, biotech, and leading academic ... customers + Selling complex solutions and services associated with traditional proteomics applications At Abcam we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles… 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
- Kelly Services (Sunnyvale, CA)
- …The **_Sr. Quality Specialist_** is responsible for supporting quality systems activities related to assay development, especially, design control and risk management ... activities in accordance with FDA and ISO regulations. This position is part of the Product Lifecyle Quality group in R&D and reports to the Sr. Manager, Product Lifecyle Quality and will be onsite based, located in **Sunnyvale, California.**… more
- Insight Global (San Diego, CA)
- …who will provide global regulatory expertise and strategic leadership to our IVD product development teams. This position is focused on pre-market development ... role also offers the opportunity to work alongside the IVD Quality team in the development and implementation of...members to maximize chances for first pass approval of IVD regulatory submissions, compliant with the appropriate regional or… more
- Fujifilm (Harrisburg, PA)
- …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
- Danaher Corporation (Richmond, IL)
- …Leica Biosystems is responsible for working with cross-functional teams to bring IVD (In-Vitro Diagnostic), Research (RUO) and Laboratorial products to market and ... three years' equivalent experience + Minimum of two years' experience within medical device/ IVD . + FDA (Class I & II) and Health Canada regulatory knowledge… more
- ThermoFisher Scientific (Middletown, VA)
- …Diagnostics Division (CDD) within our Specialty Diagnostics Group, provides innovative diagnostic ( IVD ) solutions for select IVD market segments and has been ... a trusted supplier in the IVD industry for over 40 years. CDD provides products...credentials and strong financial competence + Experience in the IVD or Life Sciences industry is a plus +… more
- Regeneron Pharmaceuticals (Armonk, NY)
- …expected to manage and deliver the execution of diagnostic projects (CDx, IVD , etc.) within Regeneron's drug development pipeline in partnership with Diagnostic ... Strategy Leads, IVD Regulatory Affairs. This is a leadership role within...must have strong expertise in drug development planning and CDx/ IVD development with pharmaceutical companies. **This role might be… more
- Kelly Services (Sunnyvale, CA)
- …authorities. + Update FDA establishment registrations and device listings for IVD products. + Maintain and administrate regulatory dossier management system. + ... Assign GMDN and UDI (GTIN) codes to IVD products. + Maintain and administrate UDI Management software...lines or manufacturing processes either for Med device or IVD products + Prior knowledge of different databases like… more
- Danaher Corporation (New York, NY)
- …closely with the cross-functional design and development team to support both IVD medical device and Research Use Only (RUO) product development and sustainment. ... marketing materials, and product changes to ensure compliance across IVD and RUO products. + Collaborate cross-functionally with global...job include: + 5+ years of regulatory experience in IVD medical devices, with a Bachelor's, Master's, or PhD,… more
- ThermoFisher Scientific (Middletown, VA)
- …Information** 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
- Abbott (Abbott Park, IL)
- …controls and risk management, as well as an understanding of the US IVD regulatory submissions process and required contents. The candidate must have experience in ... and responsibilities expected of this position include providing support for US IVD product submission reviews, and consultation in matters of Quality System and… more
- Regeneron Pharmaceuticals (Armonk, NY)
- …study conduct, sample management testing to launch) in collaboration with partners/ IVD Sponsors and central testing laboratories to support early and late-stage ... all of the relevant inputs + Develop strong relationships partnerships with IVD partners and testing laboratories + Oversee operational aspects of CDx clinical… more
