- ZOLL Medical Corporation (Irvine, CA)
- …sleep disorders. Our core product is the WatchPAT(R)️ family, a revolutionary FDA -cleared portable home sleep apnea test device, that is based on proprietary ... utilization and revenue.Essential Functions + Work in collaboration with your Region Sales Manager , Cardio Key Account Manager and VA/Gov't Account Manager … more
- Medtronic (Northridge, CA)
- …organizations to advance sensor technology. + Present technical findings and project updates to executive leadership and cross-functional stakeholders. **Design & ... diabetes devices. + Mentor and guide junior engineers and project teams in design best practices, troubleshooting, and root...activities **Regulatory & Quality:** + Ensure designs comply with FDA regulations (21 CFR Part 820), IEC 60601, and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …ensure utility systems operate within validated parameters and comply with cGMP, FDA regulations, and company safety & quality standards. + Ensure system ownership ... + Provide technical support and training for operations and maintenance personnel. ** Project Management & Collaboration** + Manage small to medium projects related… more
- Mentor Technical Group (Millbrae, CA)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... expectations, and anticipating possible barriers or obstacles that may impact the project (s) adversely and communicating these on a timely manner. + Guarantee top… more
- BeOne Medicines (Emeryville, CA)
- …Medical Monitoring Plans, CSRs (incl. China ADR Summary) and other relevant project /study documents and answer ad-hoc safety queries from ethics committees. + Lead ... (eg, clinical development, medical, regulatory, labeling) and external stakeholders (eg FDA , MHRA, EMA, other regulatory agencies). + Contribute to continuous… more
- Medtronic (Northridge, CA)
- …Quality management, CAPA, Complaints handling. + Ensure regulatory readiness and support FDA audits by maintaining validated system states (ISO 13485, HIPAA, GDPR ... CAPA optimization, or post-market surveillance trend analysis. + Certification in project management (eg, PMP), IT service management (eg, ITIL), or quality… more
- Fujifilm (Sacramento, CA)
- …Positive customer surveys, documentation accuracy and consistency, timely case and project completion, and finishing the assigned trainings are standard expectations ... level of success with yearly goals provided by your manager and metrics defined on a team level. +...with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard… more
- Charles River Laboratories (Thousand Oaks, CA)
- …data patterns. + Record, prepare, and analyze data for inclusion in project reports. + With guidance from scientific management, maintain a technical knowledge ... o Necropsy, tissue and fluid collections + Assist Operations Manager and provide coverage for monitor animal health and...drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to… more
- Parexel (Sacramento, CA)
- …(SMP) and applicable prevailing laws, GCP, and sponsor standards to achieve project goals, timelines and quality + Manage assigned operational aspects for ... (DSMM) + Partners with SCP and Country Study Operations Manager (SOM) + When required Partners with other Study...of clinical trial methodologies, ICH/GCP, Food and Drug Administration ( FDA ) and local country regulations + Must be fluent… more
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