- Abbott (Alameda, CA)
- …for completeness and accuracy, and escalate issues to the Clinical Operations Manager as needed. + Participate in cross-functional clinical team(s) in the planning ... and Reports). + May interact with RA/QA in responding to audits and FDA inquiries. + Perform other function-related activities in addition to the responsibilities as… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Product Management Team Lead (Early Phase) will have experience serving as project manager for early phase biopharma molecules and will serve as a subject matter ... strategy, and early clinical trial design. + Regulatory knowledge: Familiarity with FDA /EMA guidance for preclinical and early clinical phases. + CMC awareness:… more
- Boehringer Ingelheim (Palm Springs, CA)
- …to the HCP through facilitation of patient management and decision making process . + Identifies key ILD business needs and activities, establishes business plans ... by pro-actively working with Associate Director and Key Account Manager . + Performs all Company business in accordance with...Company business in accordance with all regulations (eg, EEO, FDA , DEA, OSHA, PDMA, EPA, PhRMA, etc.) and Company… more
- Bayer (Sacramento, CA)
- …Medical Inquires in collaboration with Medical Communications; + Adherence to SOP and FDA guidance for distribution of scientific information; + Adherence to SOP and ... strategic partnership and collaboration with territory cross-functional stakeholders (ie Area General Manager , Area Business Unit team, Field DGOS) as part of Area… more
- Meta (Burlingame, CA)
- …Prepare, submit, and manage regulatory filings across global regulatory agencies including FDA and EU submissions 3. Provide expertise on regulatory requirements and ... latitude in determining deliverables of assignments, with limited oversight from manager 15. Current experience with Software as a Medical Device product… more
- Fujifilm (Sacramento, CA)
- …to cross sell additional products and options. + Work Hospital Relations Manager , National and Government Accounts to develop relationships and implement hospital ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all… more
- Danaher Corporation (West Sacramento, CA)
- …operate reliably and efficiently. This position reports to the Sr. Manager Engineering/Maintenance/Facilities and is part of the Facilities Maintenance team located ... applicable technician licenses preferred + Manufacturing/Production environment and/or other FDA -regulated industry. + Welding and metal fabrication. Beckman Coulter… more
- Medtronic (Santa Rosa, CA)
- …expected to support a number of regulatory applications which may include, FDA Pre-submissions, PMDA consultations, original IDEs and PMAs, IDE and PMA ... a scientific discipline (engineering, physical/biological or health sciences). + Analytical, process and data visualization experience + Working knowledge of Project… more
- Primo Brands (Santa Ana, CA)
- …plant operating supplies for quality and safety. + Assist the Factory Manager with leading all company and Local quality/safety initiatives, audits, localSHE ... EPA, and local Air Quality Management District. + Knowledge of Statistical Process Control, HACCP, sanitation, and hygienic design + Familiarity with quality and… more
- Danaher Corporation (Lodi, CA)
- …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 ... of OEE and maintenance processes for compliance with Company, FDA , ISO, OSHA and GMP regulations. The essential requirements...needed to participate in the job application or interview process , to perform essential job functions, and/or to receive… more