- Sumitomo Pharma (Sacramento, CA)
- …highly motivated, and experienced individual for the position of **Associate Director, Regulatory Affairs (Oncology).** The Associate Director is part of the Global ... Regulatory Affairs (GRA) team based in the US. He/She...to achieve results + Understanding of medical terminology, and FDA and ICH regulations/guidance documents specific to clinical research… more
- Lilly (San Diego, CA)
- …expertise to regulatory scientists. + Support/assist in the preparation of regulatory reports, including NDAs, FDA annual reports and Periodic Adverse Drug ... reimbursement, and access (PRA), grant submissions and contracts; contacts with regulatory and other governmental agencies; outreach medical activities aimed at the… more
- Edwards Lifesciences (Irvine, CA)
- …to work from home as needed.** **How you'll make an impact:** The Manager, Regulatory Counsel reports to the Senior Director, Regulatory Counsel and will be ... assistance with state licensing, support for sales contracting, and other legal regulatory duties as needed. The Manager provides legal guidance to Marketing and… more
- Edwards Lifesciences (Irvine, CA)
- …and analyze accurate date of regulatory reports for submission for the regulatory bodies (eg, FDA ) + Identify technical and data issues and collaborate ... with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize… more
- Envista Holdings Corporation (Orange, CA)
- …improve product performance, reliability, and clinical outcomes, while maintaining compliance with FDA , ISO 13485, and other regulatory standards. Design & ... champion engineering excellence, and collaborate cross-functionally to deliver high-performance, regulatory -compliant solutions that elevate clinical outcomes. If you're passionate… more
- Terumo Neuro (Aliso Viejo, CA)
- …and required quantity for validation. + Provide sterilization expertise during interface with regulatory agencies, including FDA and ISO. + Support clean room ... four (4) years of related professional experience. 3. Understanding of ISO and FDA requirements for medical product sterilization and for cleanroom monitoring. 4. EN… more
- BD (Becton, Dickinson and Company) (Irvine, CA)
- …reports and presentations. Conduct verification and validation testing in accordance with FDA and ISO standards. Support regulatory submissions by documenting ... delivery systems, mechanical ventilators and anesthesia delivery systems. Experience with FDA design controls and IEC software lifecycle processes. Knowledge of… more
- Mentor Technical Group (Redwood City, CA)
- …activities. + Is responsible for overseeing work order activity compliance with respective regulatory requirements (ie FDA , DEA, OSHA). + Manage Work through the ... provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical… more
- Children's Hospital Los Angeles (Los Angeles, CA)
- …That Matters.** **Overview** **Purpose Statement/Position Summary:** The Manager, Clinical Research Regulatory Affairs is tasked with oversight and governance of ... Regulatory Affairs department and involved in the day-to-day support...experience. + Advanced knowledge of Food and Drug Administration ( FDA ) regulations and International Conference of Harmonisation (ICH) and… more
- Cytel (Sacramento, CA)
- …Medidata Rave, Oracle Inform, Veeva, or similar). + Excellent understanding of ICH-GCP, FDA , EMA, and other global regulatory guidelines. + Strong attention to ... individual brings advanced knowledge of medical terminology, clinical trial processes, regulatory requirements, and coding best practices. The Senior Medical Coder… more