- BioFire Diagnostics, LLC. (Hazelwood, MO)
- …connects everything we do. We pioneer, develop, and produce high quality in vitro diagnostic solutions that help healthcare professionals quickly and reliably ... determine a pathology or the source of a contamination and provide them with crucial information for optimal patient care. Be a part of the team that is responsible for deploying and sustaining the manufacturing of this life saving equipment. You will be… more
- Abbott (Atlanta, GA)
- …(or equivalent vocational qualifications) + Experienced in regulatory submissions for in vitro diagnostic devices and/or medical devices. + Experience of working ... within the requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC). **Preferred** **Qualifications** + 5-7 years' experience in a regulated industry with a minimum of 3 of those years directly… more
- Abbott (Pleasanton, CA)
- …vocational qualifications) + Experienced in regulatory submissions for Pharmaceutical, In vitro diagnostic devices and/or medical devices. + Experience of ... working within the requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC). **Preferred** **Qualifications** + Minimum of 5 years' experience working with Class II and/or Class III medical devices.… more
- GRAIL (Durham, NC)
- …with GRAIL's quality management system and regulatory requirements including ISO 13485, In Vitro Diagnostic Regulation, ISO 14971, 21 CFR 11, 21 CFR 820. ... + Work on abstract problems across functional areas of the business. + Identify and evaluate fundamental issues and resolutions for major functional areas through assessment of intangible variables. + Interact with executive level management requiring… more
- Amazon (Sunnyvale, CA)
- …qualifications) - . Experienced in regulatory submissions for Medical Devices, In Vitro Diagnostic Devices, Pharmaceutical and/or Biologics. - . Experience of ... working within the requirements of 21 CFR 820, ISO13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC). - . 5-7 years' experience in a regulated industry with experience working with Class II and/or Class III devices. - .… more
- Caris Life Sciences (Irving, TX)
- …of experience in marketing/communications/product management. + Prior healthcare experience (in vitro diagnostic , medical device, pharmaceutical, etc.) + Firm ... understanding of marketing principles and demonstrated experience successfully managing marketing projects from beginning to end. + Must be able to work across levels in the organization to drive projects to completion. + Must be well-organized and can meet… more
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- …MDR/IVDR experience. + History of successful 510(k) clearances and/or PMA approvals of in vitro diagnostic devices is a plus. + Flow cytometer experience a plus. ... + Premarket Experience: Experience supporting medical device regulatory submissions; proven experience with application of quality and regulatory requirements for IVD manufacturers in the design and development of medical devices. listings, establishment… more
- Kelly Services (Carlsbad, CA)
- …role involves conducting various analyses and quality control tests on in- vitro veterinary/medical diagnostic devices, maintaining microbiological organisms, and ... and resource management. **Responsibilities:** + Conduct detailed analyses on manufactured in- vitro veterinary and medical diagnostic devices. + Execute quality… more
- Merck (Rahway, NJ)
- …experience. **Required Experience and Skills:** + Diagnostics/In Vitro Diagnostics. Experience in Oncology/non-oncology companion/complementary diagnostic ... to the world by facilitating effective, efficient, and compliant drug/ diagnostic regulatory strategies and approaches across geographies. Under direction of… more
- Merck (Rahway, NJ)
- …management and strategic marketing experience in oncology within pharma and/or in vitro diagnostics + Oncology diagnostic / Precision Medicine product launch ... the Global Asset Leaders and Global Business Leaders in Human Health (HH), Diagnostic Digital Experts and Diagnostic Development Teams (DxDTs) in our Company's… more