- Merck & Co. (Boston, MA)
- …partners.-Position reports to Senior Principal Scientist, CDx.Primary Responsibilities:Direct CDx/ IVD development projects, including associated DP efforts when ... needed, within Translational MedicineLead cross-functional CDx (and where relevant, DP) development teams for various assets/biomarkers (including Regulatory, Commercial, Business Development, Project Management, Operations, Clinical Development, Statistics,… more
- GRAIL (Menlo Park, CA)
- …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
- Kelly Services (Sunnyvale, CA)
- …**Workplace:** Onsite in Sunnyvale, CA. **Position Title:** Senior Scientist, IVD Assay Verification **Position Type:** One-year contract **Pay rate:** $50-65 ... business by applying problem-solving skills and strategies for the verification of IVD tests on their platform. + Effectively manage experiments with shifting… 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
- Danaher Corporation (West Sacramento, CA)
- …At first glance, you'll see that for more than 80 years we've been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a ... team where you can be heard, be supported, and always be yourself. We're building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you'll see we are invested in you, providing the opportunity to build a… more
- Kelly Services (Sunnyvale, CA)
- …+ Prepare regulatory submissions and interacts cross-functionally to ensure OTD of product launches. + Interact with regulatory agencies/health authorities to resolve ... queries and to obtain product approvals with a focus on US and EU IVDR and WHO PQ submissions as required. + Serves as representative to gather and interpret new and changed regulations and guidelines in US and EU. + Implements continuous improvements 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
- Fujifilm (Indianapolis, IN)
- …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
- 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
- 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
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- …program meets EH&S requirements. + Familiar with GMP's, ISO requirements, the IVD Directive, CE marking, Six Sigma and LEAN principles. **Minimum Qualifications:** + ... years' experience in product Manufacturing Sustaining Engineering in a regulated (ISO/ IVD ) regulated operation **Education and Experience:** + Bachelor's Degree is… more
- ThermoFisher Scientific (Tampa, FL)
- …a Senior Business and Sales Development Manager to drive global success in the IVD sector within the Diagnostic Services team (DX Services). DX Services is a ... Thermo Fisher Scientific, providing services and products to leading IVD manufacturers globally. **Position Summary:** Lead strategic account relationships, manage… more
- Roche (Indianapolis, IN)
- …+ Provide RWD leadership for evidence generation using RWD, supporting In-Vitro Diagnostics ( IVD ) and CDS product portfolio at Roche Diagnostics. + Drive the primary ... primary evidence generation mechanism to achieve regulatory and reimbursement objectives for IVD and CDS products being developed across Roche Diagnostics. + Develop… 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
- 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
- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- …assessing regulatory risks for products (for both registration and change), driving IVD (as well as RUO and Industry) products through government/regulatory approval ... Science background is preferred. 3+ years in regulatory affairs required, medical device/ IVD industry preferred. Knowledge, Skills and Abilities: + Knowledge of MD/… 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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