- 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
- 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
- Abbott (San Diego, CA)
- …preferably in a medical device/diagnostics or other regulated environment. Direct experience with IVD instrumentation is a plus. + Minimum of 10 years of experience ... in a medical device/diagnostics or other regulated environment. Direct experience with IVD instrumentation is a plus. + Relevant work experience will include… more
- Actalent (San Diego, CA)
- …the labeling process for both new and existing in vitro diagnostic ( IVD ) and medical device (MD) products. This role requires cross-functional collaboration to ... reviewers based on a strong understanding of regulatory standards and guidelines for IVD and MD labeling. + Proofread and perform quality control checks on product… more
- WTW (Los Angeles, CA)
- …a Producer and Client Advocate within one of our Industry Vertical Divisions ( IVD ) or Geographical Divisions. + Retail & Distribution + Financial Institutions + ... mentor to other ACAs, a partner/ team member for others within your IVD , or an ACA Leader. **Note** : Employment-based non-immigrant visa sponsorship and/or… more
- ThermoFisher Scientific (Fremont, CA)
- …chemicals and biologicals to manufacture reagents, calibrators, and controls for IVD immunoassay use. Participates in projects to drive process improvements. **Key ... great time-management skills! + Self-sufficient, self-motivated, and focused + IVD immunoassay manufacturing experience preferred + General laboratory skills and… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …regulatory bodies. + Understanding of regulations, standards and guidelines related to IVD , and/or medical devices and quality systems including 21 CFR, CE- IVD ... , ISO 13485, etc. **Why Join Us?** A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we… more
- Hologic (San Diego, CA)
- …related to Design Control efforts in accordance with FDA, ISO, and other IVD regulations. You will also support the company's quality system activities and design ... control/quality product design experience in a regulated environment, ideally in the IVD space. + Working knowledge of Quality Management System for Medical Device… more
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- …validating flow cytometry clinical panels and have a broad understanding of IVD and laboratory developed test (LDT) regulatory environment. By interacting with ... US LDT development + Deep understanding of regulations pertaining to US LDT and IVD development, IVDR regulatory experience is a plus + Deep understanding of CLSI… more
- ThermoFisher Scientific (Carlsbad, CA)
- …as the development of Research Use Only (RUO) and In Vitro Diagnostic ( IVD ) software products and platforms. To be successful, this high-visibility position demands ... + Guide the development, verification, validation, and release of RUO and IVD software applications, aligning them with product and market needs, regulatory… more