- 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
- 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 (Jefferson City, MO)
- …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 and 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
- 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
- Healgen Scientific Limited (Houston, TX)
- …of healthcare communications! Healgen is a leading global in-vitro diagnostics ( IVD ) developer and manufacturer, dedicated to advancing healthcare worldwide through ... content creation. Experience in the healthcare, pharmaceutical, or in vitro diagnostics ( IVD ) industry is a plus. Proficiency in Adobe Creative Suite (Photoshop,… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …regulatory bodies. + Understanding of regulations, standards and guidelines related to IVD , and/or medical devices and quality systems including 21 CFR, CE- IVD ... , ISO 13485, etc. **Why Join Us?** A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we… more
- Hologic (Marlborough, MA)
- …authoring/supporting/maintaining SOPs. + Deep understanding of global medical device and/or IVD regulations. + Experience managing projects in a matrixed environment ... a QMS. + Firm understanding of regulatory challenges in the medical device or IVD space. + Solid computer skills in Microsoft Office programs (ie Word, Excel,… more
- ThermoFisher Scientific (Suwanee, GA)
- …experience in technical support, field service, or field applications-preferably in the IVD sector + Experience managing and developing people in technical or ... service roles + Familiarity with immunoassays and IVD systems + Exposure to LIS/middleware platforms is a plus + Experience with complaint handling, QA/regulatory… more
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