- 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
- Kelly Services (Oakland, CA)
- …new or revised standards, expanded claims, recalls, adverse events, and impact on the IVD product and provide the appropriate data to the Project Lead to prepare ... regulatory bodies is highly preferred. . Experience with US and international IVD regulations . Broad knowledge of post market surveillance regulations, practices,… 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
- Insight Global (San Diego, CA)
- …who will provide global regulatory expertise and strategic leadership to our IVD product development teams. This position is focused on pre-market development ... role also offers the opportunity to work alongside the IVD Quality team in the development and implementation of...members to maximize chances for first pass approval of IVD regulatory submissions, compliant with the appropriate regional or… more
- Kelly Services (South San Francisco, CA)
- …who will provide global regulatory expertise and strategic leadership to our IVD product development teams. This position is focused on pre-market development ... role also offers the opportunity to work alongside the IVD Quality team in the development and implementation of...members to maximize chances for first pass approval of IVD regulatory submissions, compliant with the appropriate regional or… more
- Fujifilm (Sacramento, CA)
- …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
- 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
- Danaher Corporation (Sunnyvale, CA)
- …procedures and assay prototypes under minimal supervision. + Develop infectious disease IVD tests based on design input requirements by following design control. + ... business by applying problem-solving skills and strategies for the development of IVD tests on the GeneXpert platform. + Maintain detailed experimental records, and… more