- FocusKPI Inc. (Mountain View, CA)
- …+ Meeting with key stakeholders (PM, Head of User Experience and Human Factors, Regulatory Affairs , Head of Engineering) to understand key milestones for product ... development. + Working with recruiting vendors to recruit participants for a study (includes writing a screener, securing budget approval, and communicating with the recruiting vendor leading up to the study). + Writing study plans that use appropriate methods… more
- Envista Holdings Corporation (Brea, CA)
- …launches, events, dealer support, and asset development. + Collaborates with Legal, and Regulatory Affairs as well as Key Opinion Leaders, Product Management, ... R&D, and Sales in the creation and approval of marketing and sales assets. + Maintain and manage all marketing assets in the document control system (Master Control) and well as sales enablement tools and or SharePoint. + Manage the events process and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …stakeholders to establish strong working relationships with quality groups, colleagues in Regulatory Affairs , Global Trade Ops, Global Commercial Operations & ... & cluster (group of countries) QA leads with interpreting the local & regional regulatory requirements as they pertain to the distribution of Gilead products + Act… more
- Abbott (Pleasanton, CA)
- …information from varied disciplines including Clinical Medicine, Engineering, Marketing and Regulatory Affairs required. + Medical device industry experience. + ... with US Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.… more
- City National Bank (Los Angeles, CA)
- …interacting with regulatory agencies, including exam management and other regulatory affairs . * For Banking Compliance related roles, Certified Compliance ... ensuring controls are in place to mitigate compliance risk. Maintaining regulatory change management, policies and procedures, training, and advisory matters for… more
- Astrix Technology (CA)
- …+ Quality Control, Quality Assurance, Quality Systems, Document Control + Regulatory Affairs + Laboratory Personnel (Chemists, Microbiologists, Lab Technicians, ... Lab Coordinators) + Process Development (Upstream or Downstream) + Manufacturing Associates + Project Coordinators & Project Managers + and more We are an equal opportunity employer and all qualified applicants will receive consideration for employment without… more
- Stryker (Irvine, CA)
- …by building strong relationships across technical teams and business units-including Regulatory Affairs , Quality, Marketing, Clinical, Operations, and Finance-to ... teams through risk management (eg, FMEA), and reviewing or delegating approval of regulatory documentation in compliance with FDA 21 CFR Part 820 and ISO 13485.… more
- Catalent Pharma Solutions (San Diego, CA)
- …with at least five (5) years' of experience in Quality Assurance or Regulatory Affairs with progressive responsibilities; + Experience in managing people, ... Safety, Quality performance, Operational Excellence, continuous improvement, error reduction, regulatory compliance, and sound fiscal responsibility. Lead the development… more
- Danaher Corporation (Vista, CA)
- …procedures and transfer schedules + Work closely with Research and Development and Regulatory Affairs on deliverables for global regulatory submissions, ... including FDA pre-submissions, 510k, and IVDR CE certifications + Participate in the performance and documentation of internal and external audits and respond to audit findings by proposing and implementing necessary corrective actions The essential… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …This role works in close partnership with R&D, Enterprise Security, Quality, Regulatory Affairs , Legal, business leaders and functional authorities at corporate, ... teams. Oversee delivery of all required product security quality and regulatory documentation associated with product launches in Dispensing. Champion initiatives… more