- ICON Clinical Research (Raleigh, NC)
- Senior Manager, Regulatory Affairs - IVD ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive ... mission to shape the future of clinical development. Sr Manager, Regulatory Affairs - IVD Location: US Remote, Portland, OR area preferred We are currently seeking a… more
- Sanofi Group (Cambridge, MA)
- …supporting the medical device, combination product, digital health and in-vitro diagnostic ( IVD ) products within the Sanofi portfolio of products. The team is part ... team is accountable for developing and implementing global regulatory strategies for device and IVD products, intended to be used alone or in combination with a drug… more
- Caris Life Sciences (Tempe, AZ)
- …with the study personnel. Job Responsibilities Support, manage and/or coordinate IVD /CDx clinical study activities. Clinical study representative for project and ... BS Degree in a scientific discipline with 3+ years of experience in IVD clinical studies. Understanding of Good Clinical Practices (GCP) and other relevant… more
- WTW (Columbus, OH)
- …and Client Advocate within our Global Natural Resources Industry Vertical Division ( IVD ). The Associate Client Advocate (ACA) owns client service activities and ... mentor to other ACAs, a partner/ team member for others within your IVD , or an ACA Leader. Note: Employment-based non-immigrant visa sponsorship and/or assistance is… more
- Twist BioScience (South San Francisco, CA)
- …Industry.Experience in Quality Assurance/Regulatory requirements in medical devices, IVD , EU IVDR/MDR, pharmaceuticals or biotechnology industry.Experience and ... knowledge of Next Generation Sequencing, Synthetic Biology Manufacturing, and Gene Manufacturing highly desirableExperience with document management systems required.Experience with Learning Management Systems.Experience with MS Office Products… more
- Danaher Corporation (Chaska, MN)
- …a plus if you also possess previous experience in Experience in IVD Medical device or Pharmaceutical Manufacturing ASQ Certification Beckman Coulter Diagnostics, a ... Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher… more
- WTW (Philadelphia, PA)
- …recommendations for associate coaching. Conduct regular meetings with operation leaders within each IVD , via Teams or in person, when possible, to review and address ... challenges, and explore opportunities to include DSO efforts for sediment, cash on account and bad debt items. Travel to field offices, including Manila and Mumbai, as needed, to build and maintain relationships, resolve client issues, address client needs,… more
- Bio-Techne (Minneapolis, MN)
- …through KPIs and data-driven decision making Experience leading in regulated settings (RUO; IVD or GMP exposure is a plus) Financial acumen in budgeting, expense ... management, and forecasting History of successfully introducingnew technologiesinto manufacturing and scaling processes effectively Comfortable managing change and guiding cultural evolution within dynamic organizations Strong communicator with high integrity,… more
- Roche (Kansas City, MO)
- …laboratory LIS department Current or previous experience working for a clinical IVD vendor Highly proficient in communicating and presenting clear verbal and written ... technical information to both external and internal audiences with the ability to influence without authority Additional Information This is a field based role - Travel in this role estimated 75%+. Multiple positions available The expected salary range for… more
- Bio-Techne (Minneapolis, MN)
- …maintain assay databases. These immunoassay products include Quantikine, DuoSet, Luminex, IVD kits, and related product lines. ESSENTIAL FUNCTIONS | Perform ELISA ... assays according to procedures in order to check in-process and final product for quality performance. | Reduce and evaluate data from assays; record data on proper documents. | Assist in transfer of new products & technologies from development including… more
- Caris Life Sciences (Phoenix, AZ)
- …Quality experience within Medical Devices, Clinical Laboratories, or IVD environments. Direct experience supporting Complaint Handling, CAPA, Deviations, ... or related Quality System processes. Working knowledge of applicable regulatory standards and frameworks, including FDA (21 CFR), ISO 13485, CAP/CLIA, and other international regulations. Proficiency in QMS and data management systems, such as DOT Compliance,… more
- GRAIL (Concord, NH)
- …monitors and communicates changes in regulatory policies and In Vitro Diagnostic ( IVD ) requirements to project teams and leadership. They may manage and provide ... in regulatory, development, clinical affairs, quality, or program management within the IVD , medical device, or pharmaceutical industries. + Regulatory affairs and … 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 (Norcross, GA)
- …Four to ten years of related work experience. + Experience in IVD development (software/system/assay focus) required + Science or Engineering Degree Preferred ... **Skills & Capabilities:** + Excellent written and verbal communication skills. + Excellent analysis, troubleshooting, and debugging skills. + Ability to perform in a fast-paced, agile environment. + Ability to operate independently and exercise good judgment… more
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- …support the global commercialization of new or modified in vitro diagnostic ( IVD ) devices. The ideal candidate will have strong experience in international ... global commercialization of new or modified in vitro diagnostic ( IVD ) devices as well as research use only (RUO)...responsibilities:** + Develop and execute international regulatory strategies for IVD device registrations outside the US and EU. +… more
- IQVIA (Wayne, PA)
- …on delivering tailored solutions to the **medical device and in vitro diagnostics ( IVD ) industries** . The **MedTech Mid-Market Account Manager** will play a pivotal ... account expansion** across a defined **portfolio of In Vitro Diagnostics ( IVD ) clients - including Diabetic Care, Oncology-related Molecular and NGS Testing,… more
- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- …Fields) with 6 years of experience in a regulated medical device/ IVD industry employment position such as post-market surveillance, quality assurance, regulatory ... Scientific Fields) with 4years of experience in a regulated medical device/ IVD industry employment position such as post-market surveillance, quality assurance,… more
- ThermoFisher Scientific (Austin, TX)
- …2-4 years of proven experience in Animal Health Diagnostic (preferred) or Human IVD Regulatory Affairs. This experience may include a combination of Animal Health ... VDx as well as US IVD and CE- IVD experience. + Demonstrated ability to maintain regulatory permits and licenses. + Proficiency in preparing regulatory compliance… more
- Hologic (San Diego, CA)
- …to gain in depth knowledge of US and OUS quality regulations for IVD products. + Identifies and implements process improvements to reduce customer complaints and ... in identifying technical solutions to customer-facing problems associated with IVD products is desirable. + Demonstrated expertise in technical investigation,… more
- Caris Life Sciences (Tempe, AZ)
- …the study personnel. **Job Responsibilities** + Support, manage and/or coordinate IVD /CDx clinical study activities. + Clinical study representative for project and ... a scientific discipline with 3+ years of experience in IVD clinical studies. + Understanding of Good Clinical Practices...a scientific discipline with 3+ years of experience in IVD clinical studies. + Knowledge of Next Generation Sequencing.… more
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