- Norstella (Sacramento, CA)
- …to clients while adhering to regulatory requirements such as HIPAA, GDPR, and FDA RWE guidance. + Support client engagements by participating in scoping discussions ... and helping design custom RWD solutions that address key clinical, regulatory, and business questions. + And other duties as assigned. **Qualifications:** + Advanced degree (Master's or Doctorate) in Biostatistics, Epidemiology, Public Health, Pharmacy… more
- Abbott (Santa Clara, CA)
- …development and manufacturing teams + Prepare robust regulatory applications ( FDA and international regulatory agencies) to achieve departmental and organizational ... objectives + Assist in the development of multi-country regulatory strategy and update strategy based upon regulatory changes + Support pre and post approval clinical strategy and submission activities + Anticipate regulatory obstacles and emerging issues… more
- Stanford Health Care (Palo Alto, CA)
- …nursing to coordinate drug therapy. + Participates in audits from the sponsors, FDA , DEA, NIH and other regulatory agencies as needed. **Education Qualifications** + ... Bachelor's in Pharmacy from an accredited college or university. **Experience Qualifications** + Two (2) years of progressively responsible and directly related work experience. + One (1) year if completed a PGY1 residency. **Required Knowledge, Skills and… more
- Envista Holdings Corporation (Pomona, CA)
- …automation within manufacturing environment. + Familiarity with health and safety regulations ( FDA Regulations & ISO 13485 Knowledge) is plus + Must possess ... effective and verbal communications skills. + Must possess good organizational and prioritization skills. + Must be able to focus on all details and requirements of current medical device **Travel ability:** + To perform this job successfully, an individual… more
- BeOne Medicines (Emeryville, CA)
- …implementation in multi-institutions and research settings in accordance with FDA regulations and Good Clinical Practice guidelines, tracking and budgeting. ... This role will be instrumental in planning and executing GMA programs and will require the ability to collaborate across other GMA functions and non-medical functions (eg, Marketing, Market Access, HEOR, Legal, Compliance, Regulatory, etc.). This position will… more
- ZOLL Medical Corporation (San Jose, CA)
- …involving electromechanical and/or catheter-based products (preferred). + Lean methodologies, FDA , ISO. Knowledge, Skills and Abilities + Solid background in ... mechanical, and/or materials engineering + Able to use Solid Works to document fixtures and assembly aids + Knowledge of Statistical software (Minitab, JMP, etc) + Able to collaborate effectively in cross-functional teams + A positive and enthusiastic attitude… more
- Fortrex (Los Angeles, CA)
- …450 plantas que limpia diariamente en norte America. Nosotros abarcamos USDA, FDA e instalaciones procesadoras de comida CFIA. Nuestros clientes trabajan fuertemente ... para perfeccionar sus productos y Fortrex se asegura de que esten protegidos. Fortrex es un empleador de igualdad de oportunidades. **LO QUE OFRECEMOS:** + Seguro Medico, Dental y Vision + Seguro de Vida Basico + Plan de Jubilacion 401K + Dias Festivos pagadas… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …scientific meetings. + Represent BDB externally with regulatory agencies, notified bodies, FDA , etc. + Ensure customer perspectives are incorporated into all aspects ... of product development. + Engage with related industrial and medical institutions to stay updated on emerging trends in the field. + Identify promising new clinically relevant technologies and/or assays. + Contribute to business strategy. **Minimum… more
- IQVIA (Valencia, CA)
- …deliverables + Proficiency in laboratory terminology and regulatory standards including FDA , GLP, ICH, ISO HL7 + Excellent problem-solving and communication skills ... with a customer-focused mindset **What We Offer You:** We put our employees at the center of everything we do and are committed to providing them, and their families, with benefits that meet their diverse and changing needs. We invest in integrated benefits… more
- Terumo Neuro (Aliso Viejo, CA)
- …spatial packaging of components. 7. Working knowledge of medical devices and FDA regulations. 8. Experience with CAPA systems, including complaint handling. 9. ... Ability to receive the appropriate inoculations required to enter an operating room environment. **External-Facing Title:** Staff Optical Engineer, R&D **Posting Country:** US - United States **Salary Range:** $111,000 - $146,000 (Compensation could be… more