- Sumitomo Pharma (Sacramento, CA)
- …Team meetings. + Represent PV Operations on cross-functional program and project teams; support PV Medical Safety activities on cross-functional program and ... project teams, as required. + Coordinate responses to ad...and/or neurology is strongly preferred. + Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for… more
- Philips (San Diego, CA)
- The Sr. Manager -Software Design Assurance will play a critical role in managing/supporting the Software Design Control process for new/existing Image Guide Therapy ... right fit if:** + You have a minimum of 8+ years' experience in FDA regulated, IEC 62304 medical device software environments (SiMD/SaMD), with a focus on Software… more
- Abbott (Santa Clara, CA)
- …and software, vessel closure devices and peripheral stents. This **Regulatory Affairs Manager ** position is an onsite opportunity working out of our Santa Clara, ... development and manufacturing teams + Prepare robust regulatory applications ( FDA and international regulatory agencies) to achieve departmental and organizational… more
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- …your best self. Become a **maker of possible** with us. The Plant Manager reports to the Sr. Director of Global Manufacturing. The incumbent provides leadership ... active and effective capital planning and management, and effective project planning and execution in situations where supply chain...take calculated risks. + Knowledge of GMP, ISO and FDA regulations specific to the life sciences industry. +… more
- Pfizer (San Diego County, CA)
- The **Senior Manager , Global Labeling Lead (GLL)** has overall accountability for the development and execution of global labeling strategy for their assigned ... and risk mitigation + Manage label negotiations with US FDA and EMA + Provide guidance on labeling regulations,...strength in logical, analytical, and writing ability + Strong project management skills and attention to detail + Proven… more
- Amgen (Thousand Oaks, CA)
- …the lives of patients while transforming your career. **CD&A - Competitive Intelligence Manager , R&D CI** **What you will do** Let's do this. Let's change the ... BioMedTracker, Cortellis Intelligence, Evaluate Pharma, Datamonitor, IPD analytics, PharmaProjects, Drugs@ FDA , PubMed, AlphaSense, Factset, and USPTO patents + Work… more
- Gilead Sciences, Inc. (Foster City, CA)
- …especially Outlook. + Good understanding of Microsoft Office SharePoint. + Experience using project management tools such as MS Project or Smartsheet. + Graphic ... operations or clinical trial management experience. + Knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of… more
- Terumo Neuro (Aliso Viejo, CA)
- …+ Interface with monitors/CROs to address and resolve queries. + Work closely with Project Manager (s) to ensure clinical studies are conducted in accordance with ... coordinating clinical research activities in accordance with ICH Good Clinical Practices, FDA guidelines, local regulations, and MicroVention SOPs. Job duties: + As… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …a **maker of possible** with us. **Position Summary** The Senior Manager of EMI (Electromechanical Instruementation) Quality Sustaining Engineering reports to the ... EMI plant locations will report directly to the Senior Manager and are under their authority for performance reviews,...evolving business. + Provide operations and quality leadership during FDA and notified body site inspections. + Interface with… more
- Medtronic (Irvine, CA)
- …projects, prepares the statistical component of protocols which meet project objectives, health authority guidelines, and clinical trial methodology standards. ... a leadership role in responding to relevant questions from FDA , FDA Advisory Panels, and/or other regulatory...and the statistics group. + Attends and contributes to project and department meetings. **Must Have (Minimum Requirements):** To… more