- Fujifilm (Sacramento, CA)
- …Speech Recognition tools, as well as actual dictation functionality when Fuji Dictation software is utilized. + Maintains a clear understanding of FDA ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all… more
- Gilead Sciences, Inc. (Foster City, CA)
- …relationships + Understanding of the pharmaceutical payer marketing that includes FDA regulatory and legal environment (PIE, FDAMA-114, etc.) + Proven ... preferred + Understanding of the pharmaceutical payer marketing that includes FDA regulatory and legal environment (PIE, FDAMA-114, etc.) + Computer aptitude… more
- Medtronic (Los Angeles, CA)
- …in the operating room, so healthcare/surgical setting experience + Familiarity with FDA product requirements and regulatory guidelines + Experience with robotics or ... understand schematics and engineering drawings + Familiar with the FDA 21 CFR, CGMP for Medical devices + Demonstrable...Microsoft Office products as well as ERP and CRM software packages (such as SAP, ServiceMax and SalesForce.com) +… more
- Charles River Laboratories (Northridge, CA)
- …manner. + Understand and correctly use the Blood Establishment Computer Software (BECS). + Responsible for the evaluation, management, and documentation of ... the development of 100% of the current commercially available FDA -approved immunocellular therapies. Our mission is to provide a...drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to… more
- Sutter Health (Berkeley, CA)
- …for the validation, development and/or implementation of new procedure, policies, equipment and software updates in the blood bank. The BB Lead maintains the lab ... registrations with ICBBA and FDA , and participates in renewal process of laboratory Biologics...KNOWLEDGE** In depth knowledge of requirements of CAP, ABBB, FDA and other accrediting agencies and current transfusion medicine… more
- Oura (San Francisco, CA)
- …to have you on our team if you have: + Minimum of 5+ years experience in software engineering, of which 2+ years were as a manager of software engineers. + ... appreciate if you have: + 8+ years experience in software engineering, of which 4+ years were as a...women's health or wellness (strongly preferred). + Experience with FDA -regulated products or other regulated health industries. + Experience… more
- Kelly Services (Sunnyvale, CA)
- …The Regulatory Affairs Process Specialist will work with the SAP (ERP System) software to maintain accurate regulatory product blocks and releases. They will support ... dossiers and approval licenses, including but not limited to software validation and data entry + The Regulatory Affairs...body or rest of world health authorities. + Update FDA establishment registrations and device listings for IVD products.… more
- ThermoFisher Scientific (San Francisco, CA)
- …Skills, Abilities** + Demonstrable understanding of applicable regulatory requirements (ISO, ICH, FDA , EMA and USP) as it relates to analytical method transfer, ... a detailed environment. + Proficiency with personal computers, business software (eg, MS Office) and technical software ...business software (eg, MS Office) and technical software (eg, Quality Management System (QMS) software ),… more
- Fujifilm (Sacramento, CA)
- …trends, best practices, regulations, and a wide range of hardware and software products. This position requires interaction with sales, technical support, field ... point of contact between Engineering and Integration for new products, software changes including testing, and new information dissemination. Responsible in… 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. ... + Leads the IIT study progress, milestones, and payments within trial management software tool. + Manages Trial Management Software vendor, recommending and… more