- 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
- Hologic (San Diego, CA)
- Scientist - Post-Market Quality Technical Investigation ( IVD ) San Diego, CA, United States Discover a career with real meaning. One that offers the opportunity to ... least 2 - 4 years of relevant industry experience, preferably in the IVD or pharmaceutical space + Good knowledge of microbiology, molecular biology, biochemistry,… more
- IQVIA (Carlsbad, CA)
- …to ensure that studies adhere to FDA regulations, Good Clinical Practices, IVD directives, and client policies and procedures. **Experience, Skills and Knowledge ... Requirements** + ≥2 years of experience as a Clinical Research Associate, with specific in vitro diagnostics study experience + CRA certification by recognized professional organization is a plus, but not mandatory + Excellent oral and written communication… 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
- Grifols Shared Services North America, Inc (San Diego, CA)
- …+ Provide QA/Engineering support as the quality representative on cross functional teams for new product development of reagents, assays and software, including ... software development lifecycle, SDLC. + Independently write, review, and approve technical documentation including plans, analytical and clinical protocols and reports. + Design control: Provide guidance to project managers on design documentation requirements… more
- Amgen (Washington, DC)
- …within R&D Quality. This role supports the use of In-Vitro Diagnostics ( IVD ), including Companion Diagnostics (CDx), within Amgen's global clinical trials. This role ... the implementation of a proactive and risk-based Quality strategy for IVD medical devices, including collaborations with diagnostic partners (testing laboratories).… more
- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- …of a dynamic group that is shaping the future of in vitro diagnostic ( IVD ) products. We are seeking a highly motivated Associate Staff Scientist to drive performance ... documentation in product lifecycle management for the regulatory validation of cutting-edge IVD products. This is an exceptional opportunity for a Master or… more
- Fujifilm (Columbus, OH)
- …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
- Adecco US, Inc. (Irvine, CA)
- …this role, you will lead R&D efforts to develop reagents to enable new Biomarker/ IVD assays and be responsible for timely product launches. You will develop reagents ... *Lead R&D efforts to develop reagents to enable new Biomarker/ IVD assays. Examples of reagents include, but not limited...* Minimum 1-3 years of related industrial experience in IVD R&D for PhD * Minimum 8 years of… more
- ICON Clinical Research (Boston, MA)
- …Reporting to the Sr. Director, Design Controls, provide support for the ICON IVD Design Control process as follows: + Drafting of Design Control Procedures, ... (TFs) to ensure completeness and accuracy. + Execution of strategic plans for IVD design control activities in alignment with company objectives and ensuring all … more
- Interstate Blood Bank (Columbus, OH)
- …Skills, and Abilities:** + Must have previous sales or business development experience in IVD or related field. + Must have a strong work ethic and energetic style; ... expectations. + Must have strong technical knowledge of the IVD disease state products. + Must have a good...products. + Must have a good understanding of the IVD manufacturers product lifecycle from R&D through to ongoing… more
- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- …with procedure, and therefore regulatory standards and enhancing the safety and effectiveness of IVD and non- IVD products. The overall objective of the role is ... regulatory affairs, R&D or equivalent regulated industry employment position, medical device/ IVD industry preferred + 4+ years leading projects Knowledge, Skills,… 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 ... of 3 years equivalent experience + Minimum of two years' experience within medical device/ IVD . + FDA (Class I & II) and Health Canada regulatory knowledge including… more
- Kelly Services (Irvine, CA)
- …efforts in developing reagents and assays to support new biomarker and IVD capabilities. This role will focus on allergen characterization, extraction, purification, ... Key Responsibilities * Develop reagents for new biomarker and IVD assays, including allergens and autoimmunity assays. * Design...a related field. * 1-3 years of experience in IVD R&D for PhD; 8+ years for MS. *… 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
- 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)
- …Information:** The Clinical Diagnostics Division (CDD) supplies diagnostic solutions for specific IVD market segments. It has been a trusted IVD industry ... and contract manufacturing partner for leading suppliers of in vitro diagnostic ( IVD ) products worldwide. With 35+ years of experience, we deliver quality,… more
- Danaher Corporation (Sunnyvale, CA)
- …I is responsible for the design and development of real time PCR and RT-PCR IVD assays in an FDA-QSR and ISO13485 compliant organization. This position is part of ... and following robust design control processes for CE and/or US- IVD tests. It would be a plus if you...with a preference for experience in medical devices or IVD diagnostics. + Designing oligos for microorganism detection with… 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
Related Job Searches:
Director IVD Product Management,
Senior Scientist IVD Assay