- WTW (Los Angeles, CA)
- …and Client Advocate within our Retail & Distribution Industry Vertical Division ( IVD ). The Associate Client Advocate (ACA) owns client service activities and client ... 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 assistance is… more
- Abbott (Santa Clara, CA)
- …21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC). + Effectively communicate verbally and in writing, prepare, and ... negotiate both internally and externally with various regulatory agencies. **Preferred** **Qualifications** + Bachelor's degree in science/technical discipline (engineering, life sciences, mathematics). + Minimum of 5 years' experience working with Class II… more
- GRAIL (Menlo Park, CA)
- …initiation and execution + Industry experience within in vitro diagnostics ( IVD ) highly preferred; pharmaceutical, biologics or medical device experience also ... acceptable + Thorough knowledge of GCP, ICH guidelines and other US and international clinical regulatory requirements + Working experience with an electronic data capture system, CTMS system, and eTMF system. + Experience working on Investigational Device… more
- Abbott (Alameda, CA)
- …CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC). Preferred Qualifications . 5 years' experience working with Class ... II, Class III medical devices and/or biologics/drugs. Regulatory Affairs Certification (RAC) is a plus. . Experience with 510(k) applications, PMA supplements, US device regulations, and/ or with EU and other international medical device regulations and… more
- Danaher Corporation (Lodi, CA)
- …Global Material Planning/Procurement team of 15+ reports supporting Cepheid's global IVD manufacturing factory footprint. Lead, mentor, and develop effective and ... efficient global teams. + Design and execute strategic plans to optimize materials management processes (Plan for Every Part / Inventory Management / change control execution). Design and execute daily/weekly/monthly/quarterly/etc standard work for team +… more
- Bio-Techne (San Jose, CA)
- …new product development for research use only (RUO) or in-vitro diagnostic ( IVD ) is required + Experience with biomolecule analytical separation and detection ... methods eg, HPLC, capillary electrophoresis (CZE, cIEF, CE-SDS), microfluidics is required + Must have demonstrated ability to develop commercial products of high degree of complexity + Strong track record of technical leadership, including experience working… more
- Danaher Corporation (Brea, CA)
- …in: + A scientific or highly technical and regulated industry (eg healthcare, IVD , Medical Device, Life Science, or other scientific or engineering-based fields) + ... Continuous improvement, operational excellence, and strategic execution + Solving complex problems, exercising analytical judgment, and identifying innovative solutions + Utilizing strong communication skills, with the ability to convey messages concisely and… more
- ThermoFisher Scientific (West Hills, CA)
- …+ Minimum of three (3) years of experience in manufacturing within an IVD industry or cGMP and ISO regulations for diagnostics manufacturing. + Extensive hands-on ... experience in molecular biology and recombinant DNA techniques. + Ability to make decisions and complete work within designated timeframe. + Excellent organizational and project management skills. + Strong ability to detail experiments and use PCs for data… more
- ThermoFisher Scientific (Fremont, CA)
- …prioritize schedules, ensuring product availability objectives are met while strictly adhering to IVD and cGMP standards. Additionally, you will act as a key partner ... with Quality Assurance, Engineering, Technical Operations, and other internal teams to successfully implement efficiency and delivery goals. As a leader, you will lead all aspects of an inclusive environment, building and developing talent within the team.… more
- Hologic (San Diego, CA)
- …methods, and acceptance sampling. + Experience with manufacturing and design of IVD products is desired. + Must be capable of providing presentations across ... all levels. + Demonstrated successful preparation and presentation of documentation and information for audits and inspections. **So why join Hologic?** We are committed to making Hologic the company where top talent comes to grow and giving you the tools and… more