- AbbVie (Irvine, CA)
- …team in R&D. This individual will contribute to the development of exciting new drug / device combination products for various phases of clinical studies and ... products based on user needs and product requirements, completing device design specification, conducting feasibility assessments through prototyping and lab… more
- Cordis (Irvine, CA)
- …specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and ... coronary and peripheral artery disease. With the approval of four Investigational Device Exemptions (IDEs) and an ongoing enrollment of patients, Cordis remains at… more
- AbbVie (San Francisco, CA)
- …Strategic Medical Writer is responsible for leading and writing clinical and regulatory device and drug documents in support of company objectives for the ... Aesthetics therapeutic area. Responsibilities In Aesthetics we support drug and device documents globally. The writing team participates in writing documents… more
- Edwards Lifesciences (Irvine, CA)
- …publications. + Keep abreast of new developments in statistics, data visualization, and device & drug development through literature review and attendance at ... + Previous experience in, or strong working knowledge of the medical device industry. + Experience working with external stakeholders such as payers, hospitals,… more
- Terumo Neuro (Aliso Viejo, CA)
- …FMEA, 5 WHYs etc. 6. Audit experience in quality assurance activities for medical device and drug products. 7. Experience with Root Cause Analysis, Corrective ... of four (4) years of total supplier quality experience in a medical device or a pharmaceuticals manufacturing environment. 3. Strong written and verbal communication… more
- Cardinal Health (Sacramento, CA)
- …Dossier Services + Submission Authoring & Filing + Quality Review Standards + Drug , Biologic (IV, Injectable) and Medical Device Development + Regulatory ... spanning large, publicly traded organizations to venture/private equity backed drug and medical device entities across a...to venture/private equity backed drug and medical device entities across a range of therapeutic categories and… more
- Lilly (San Francisco, CA)
- …regulatory strategy documents by leveraging team expertise, as well as scientific, drug / device clinical development and knowledge from health authorities such as ... a global regulatory strategy which supports product (including delivery device and relevant medical devices) development, registration, and lifecycle maintenance… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …related scenarios in the areas of biologic/small molecule drug substances, drug products, and drug - device combination products. + Determine regulatory ... including biologic upstream and downstream processes, analytical methods, and drug / device combination products. + Comprehensive knowledge and experience… more
- Vera Therapeutics (Brisbane, CA)
- …to commercialization. The ideal candidate will have a strong background in drug delivery systems, medical device and combination product regulations. Exceptional ... degree preferred * 8 years of experience in quality oversight of drug product device development, with a proven track record of successful product launches *… more
- Cordis (Irvine, CA)
- …specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and ... with regulatory requirements, standards, and guidelines relevant to the medical device industry and ensure that manufacturing processes adhere to these regulations.… more