- ThermoFisher Scientific (Pleasanton, CA)
- …+ Experience leading new product introduction and productivity projects in an IVD or reagent, liquid handling and consumable manufacturing environment? + Experienced ... in portfolio and stakeholder management + Experience with Continuous improvement **Knowledge, Skills, Abilities** + Strong interpersonal and presentation skills (verbal, written, and listening) + Strong communication skills and ability to multitask + Solid… more
- Abbott (San Diego, CA)
- …for years of experience. Regulatory Knowledge of (as applicable): + Background in IVD instruments and software required. + Experience with meeting global (ie, US ... FDA, IVDR, PMDA) cybersecurity, EMC, and software requirements. + Regulatory history, guidelines, policies, standards, practices, requirements and precedents + Regulatory agency structure, processes and key personnel + Principles and requirements of applicable… more
- Danaher Corporation (Lodi, CA)
- …team is responsible for the maintenance of complex manufacturing processes in our IVD Factory. This position reports to the Maintenance Engineering Manager and is ... part of the Engineering team located in Lodi, California and will be an on-site role. The schedule is Sunday to Tuesday, 5pm-5am with alternating Saturdays. In this role, you will have the opportunity to: + Oversee the Preventative Maintenance (PM) program for… more
- Abbott (Alameda, CA)
- …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 either 510(k) applications, PMA supplements, NDA, BLA, US Device regulations, US Combination Device regulations, US Biologics… more
- Abbott (San Diego, CA)
- …SW Guidelines ). + Experience in delivering products for the Medical Device IVD industry. + Experience with testing techniques for cloud solutions. + Strong written, ... verbal, interpersonal and presentation skills. + Good understanding of the TLS\HTTPS REST\SOAP protocols. **Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:** www.abbottbenefits.com… more
- Danaher Corporation (Sunnyvale, CA)
- …with related work experience. + Experience with in vitro diagnostic ( IVD ) products, preferably in molecular diagnostics or immunodiagnostics, in oncology and/ ... or infectious disease + Proficiency in Microsoft Office Suite It would be a plus if you also possess previous experience in: + A Masters or PhD in Clinical Sciences, Health/Life Sciences, Molecular Biology, Biochemistry and/or Human Physiology + Strong… more
- Abbott (Alameda, CA)
- …with in-country regulatory representatives, compile, prepare, and review medical device or IVD submissions to regulatory agencies in the APAC region. + Provide ... strategic input and technical guidance on regulatory authority queries. + Evaluate proposed design and manufacturing changes for regulatory impact and implement required regulatory actions. + Anticipate regulatory and related obstacles and emerging issues… more