- Sumitomo Pharma (Sacramento, CA)
- …oncology, and/or neurology is strongly preferred. + Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for investigational and ... marketed products. The base salary range for this role is $127,920 to $159,900. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our… more
- ZOLL Medical Corporation (San Francisco, CA)
- …sleep disorders. Our core product is the WatchPAT(R)️ family, a revolutionary FDA -cleared portable home sleep apnea test device, that is based on proprietary ... signal and analysis. 80% of patients who have sleep apnea are undiagnosed. We are committed to reach those undiagnosed patients and provide testing to promote wellness and enhance overall quality of life. WatchPAT(R)️ is commercially available within major… more
- Gilead Sciences, Inc. (Foster City, CA)
- …or therapeutic areas. + Maintains a continued awareness and understanding of FDA regulations, guidance documents, and enforcement actions with regards to advertising ... and promotion of pharmaceutical products. + May initiate and/or contribute to local process improvements for activities that relate to regulatory advertising/promotion. + May provide regulatory guidance on new marketing concepts, messages, and campaigns with… more
- Abbott (Ontario, CA)
- …developments + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, company policies, operating procedures, processes, ... and task assignments + Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors + Performs other related duties and responsibilities, on occasion, as assigned **Required… more
- ZOLL Medical Corporation (San Jose, CA)
- …Super Saturated Oxygen (SSO2) Therapy is the first FDA -approved therapy since the stent 20+ years ago to ... reduce infarct size in patients with the most severe heart attacks. Heart disease is the leading cause of death for both men and women in the US At ZOLL, your work will help to ensure cardiac patients get the life-saving therapy they need.ZOLL has been… more
- Edwards Lifesciences (Irvine, CA)
- …policies, procedures and guidelines relevant to local and/or global supply chain including FDA and ISO laws and regulations * Ability to transfer essential knowledge ... and mentor other team members on specialized skills * Ability to work in ambiguous situations and build business framework to navigate through complexity * Strict attention to detail * Ability to interact professionally with all organizational levels and… more
- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …operations. The Manufacturing Specialist will work in conjunction with the Manager , Manufacturing to coordinate all logistics pertaining to manufacturing operations. ... and other appropriate logs. 3. Works with the department manager to maintain the production schedule. 4. Request and...9. Strict adherence to procedures and practices according to FDA regulations. 10. Strong emphasis on documentation according to… 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
- Biomat USA, Inc. (Van Nuys, CA)
- …of operational priorities, and provides direct support to the Center Manager in driving performance, donor satisfaction, and continuous improvement. **Primary ... Responsibilities** + Serves as acting leader in the absence of the Center Manager as assigned. Maintains the ability to perform any/all tasks within the plasma… more
- Biomat USA, Inc. (San Diego, CA)
- …of operational priorities, and provides direct support to the Center Manager in driving performance, donor satisfaction, and continuous improvement. **Primary ... Responsibilities:** + Serves as acting leader in the absence of the Center Manager as assigned. Maintains the ability to perform any/all tasks within the plasma… more