- Roche (Santa Clara, CA)
- …+ 8+ years relevant work experience in a GMP/ISO regulated environment providing IVD instrument and/or IT and networking service within R&D, hospital or clinical ... laboratories with technical knowledge/skills and proven record of accomplishments. + Knowledge and troubleshooting experience for AWS cloud & microservices based software applications, kubernetes environment, Splunk, Grafana/Loki. + Programming knowledge using… more
- ThermoFisher Scientific (Phoenix, AZ)
- …**Preferred Attributes** + Experience building and scaling interoperability platforms in IVD or regulated healthcare environments. + Strong understanding of data ... architecture, microservices, and secure APIs. + Ability to communicate complex technical concepts to cross-functional and executive collaborators. + Passion for mentoring engineers and building high-performing, inclusive teams. **Benefits** We offer… 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
- Abbott (Abbott Park, IL)
- …and responsibilities expected of this position include providing support for US IVD product submission reviews, and consultation in matters of Quality System and ... regulatory compliance. This role will serve as a corporate liaison and technical expert primarily to the Abbott in vitro diagnostics businesses, developing and providing a strategic framework through the technical review process implemented to deliver… more
- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- …and diagnostics products. Responsibilities include conducting testing of reagents and IVD materials as well as personnel swabs. Responsibilities include working with ... the Manufacturing, Technology Transfer and other departments for data collections and validations for new product QC qualifications, organization of quality controlled materials used for QC testing, learning new techniques or workflow as required by new… more
- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- …and diagnostics products. Responsibilities include conducting testing of reagents and IVD materials as well as personnel swabs. Responsibilities include working with ... the Manufacturing, Technology Transfer and other departments for data collections and validations for new product QC qualifications, organization of quality controlled materials used for QC testing, learning new techniques or workflow as required by new… 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
- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- …Testing environments and relevant professional societies and guidelines ( eg FDA, CE-Mark IVD Directives, CAP, CLIA, WHO, IASLC, ASCCP, etc.) Proven track record of ... writing clinical study plans and study protocols Knowledge, Skills & Abilities + Strong computer skills including word processing and use of spreadsheets . Skills with database and project management software desirable. + Demonstrate ability to work… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …is preferred Experience + At least 3 to 5+ years' work experience ( IVD , Medical Device, Pharmaceutical or consulting experience is preferred) + Business experience ... may include marketing, sales, sales training, business development Knowledge, skills and abilities + Proactive self-starter with the ability to thrive in a fast-paced, dynamic environment + Strong action orientation with excellent prioritization and… 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