- IQVIA (Carlsbad, CA)
- …(CA) in countries participating in the Pharm or Dia trial. + The change from IVD Directive (IVDD) to the Regulation (IVDR) became effective in May 2022 and is a ... much stricter process. For CDx studies, there is a requirement for a joint Pharma/Dia submission or notification package to be created and submitted to each country participating in the clinical performance study. There are typically feedback rounds with… 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
- 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
- Danaher Corporation (Austin, TX)
- …support for clinical study design, analysis, and reporting for registration/pre-market approval (CE- IVD and US- IVD ) of qualitative and quantitative IVD ... have the opportunity to: + Provide end-to-end statistical analysis support for IVD product life cycle development through creation and verification of multiplex… 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
- 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 ... equivalent experience. + Minimum of two years' experience within medical device/ IVD , across a variety of regulatory submissions, compliance initiatives, and… more
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- …targeted markets globally. + Develop and execute international regulatory strategies for IVD device registrations outside the US and EU. + Collaborate closely with ... related regulatory submission experience from a medical device and/or IVD industry. + Ability to work in a fast-paced...simultaneously. + Demonstrated ability to interpret and apply global IVD regulatory requirements. + Experience with IVD … more
- ThermoFisher Scientific (Fremont, CA)
- …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
- Sanofi Group (Framingham, 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 ... developing and implementing global regulatory strategies for device and IVD products, intended to be used alone or in...+ Contribute to internal regulatory processes and procedures for MD/ IVD + Accountable for regulatory assessment for MD/ IVD… 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
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