- 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 (Lincoln, NE)
- …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 (Indianapolis, IN)
- …candidate who can provide project management expertise and project coordination for drug delivery device -related development projects. This person will interface ... the world. In 1992, Eli Lilly and Company established the Delivery Device business for the purpose of creating, developing, launching and continuously improving… more
- Bayer (Whippany, NJ)
- …and communicate scientific principles and regulatory requirements relevant to global drug - device combination product development; + Provide global regulatory ... assessments for requirements of drug - device combination products according to existing global guidelines and policies; + Lead preparations and follow-up for… more
- Lilly (Stamford, CT)
- …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
- University of Florida (Gainesville, FL)
- …verification, informed consent process and human subject protection, data integrity, device / drug accountability and compliance, and review of investigator and ... sponsors), if appropriate * Assist in regulatory management of FDA (Federal Drug Administration) required documentation on Investigational New Drug (IND)… more
- West Pharmaceutical Services (Exton, PA)
- …with matrix and cross-functional project teams required + Medical Materials, Medical Device and/or Drug Delivery Systems product development preferred + ... and demonstrated experience managing projects or programs in the medical device and pharma manufacturing industries, knowledge of applicable federal and… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …Skills: **Required:** + 6+ years of Quality Assurance experience in the Pharmaceutical ( Drug /Biologics), Drug Device Combination Product and/or Medical ... QA/GMP compliance regulations, ie: 21 CFR Part 210/211, 600, 820, Drug / Device Combination products. + As required participates in compliance inspections and… more
- University of Colorado (Aurora, CO)
- …and surveys, cognitive testing and protocol specific assessments and coordinating drug and/or device dispensing and accountability) with a high-level ... patient statuses and visits, chain of custody lab samples and study drug / device , billing notes, progress reports) that adhere to study protocols using various… more
- Lilly (Indianapolis, IN)
- …andmaintainregulatorystrategydocuments byleveragingteam expertise, as well as scientific, drug / device clinical development and knowledgefromhealth authorities ... a global regulatory strategy which supports product (including delivery device and relevant medical devices) development, registration, and lifecycle maintenance… more