- Eckert & Ziegler Isotope Products, Inc. (Valencia, CA)
- …with compliance to MDSAP, European Medical Device Directives (MDD), EU MDR/ IVD , FDA, QSR/QMSR, ISO standards, and other applicable regulatory requirements. Proven ... track record of agency interactions, product registrations. Experience in documentation and records administration. Customer service experience and handling customer complaints. Must be able to communicate clearly and succinctly and effectively over the phone,… 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
- ICON Clinical Research (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
- 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
- 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
- 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
