- Globus Medical, Inc. (San Diego, CA)
- …in Qt is a plus + Excellent oral, written, and graphical communication skills + Medical device experience in a regulated industry is a plus. Familiar with IEC ... At Globus Medical , we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team… more
- Terumo Neuro (Aliso Viejo, CA)
- …and experience. 2. Minimum five (5) years of relevant experience in product labeling in medical device field. 3. Minimum one (1) year of experience in project ... Device Labeling, 21 CFR 830 - Unique Device Identification, FDA 89-4203, ISO 15223, CDRH...(7) years of relevant experience in product labeling in medical device field. **External-Facing Title:** Sr Labeling… more
- Cordis (Irvine, CA)
- …+ Site management **Qualifications** + Minimum 3 years of experience working in the medical device space in a CRO or Sponsor setting with strong knowledge ... the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery… more
- Abbott (Alameda, CA)
- …and work experience + Minimum 10 years of related work experience with medical device product development + Has successfully led several high complexity ... + Experience designing and implementing design control tools within medical device industry. + Require strong technical...has general knowledge of regulations and standards related to medical devices (eg FDA , ISO, QSR design… more
- J&J Family of Companies (Santa Clara, CA)
- …Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated ... in engineering. + 3-5 years of experience in a medical device environment. + Knowledge of and... environment. + Knowledge of and compliance with applicable Quality System requirements such as QSRs, FDA ,… more
- J&J Family of Companies (Santa Clara, CA)
- …Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated ... to company's products. + Support company goals and objectives, policies and procedures, Quality Systems, and FDA regulations. + Other duties as assigned.… more
- Terumo Neuro (Aliso Viejo, CA)
- …writing skills as evidence by successful US FDA Class II / III medical device submissions, EU CE Mark applications, Health Canada submissions and/or rest of ... submission activities focused on US/EU/Canada and ensuring compliance to FDA and international regulatory agency requirements for Neurovascular and Peripheral… more
- Abbott (Pleasanton, CA)
- …& Quality Assurance: Ensure all test strategies and practices align with medical device regulatory standards ( FDA , ISO, IEC 62304).Support documentation, ... to define and implement comprehensive test automation strategies for Abbott's next-generation medical device software portfolio (Class II and Class III devices).… more
- J&J Family of Companies (Santa Clara, CA)
- …QSR and applicable Quality System Standards. + Experience with disposable medical device development, preferably coronary and/or vascular catheters. + Strong ... Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated… more
- BeOne Medicines (Emeryville, CA)
- …of understanding of international GCP requirements and standards in the pharmaceutical, medical device and biotech industries. + Excellent English language ... General Description: This position within R&D Quality is a senior Auditor role (as Lead...with supporting and involvement in GCP inspections (main inspectorates ( FDA , EMA, CFDI etc.,)) and other country specific inspectorates… more