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Online Resumes with "21 CFR 803"
Clinical Research - 10 Years of Experience - Near 18901
Summary: * Several years of clinical experience in the industry with excellent knowledge of drug development in different therapeutic areas including oncology, immunology, vaccines, metabolism and biosimilars. Solid clinical practice experience. * Many years of Drug Safety, pharmacovigilance, risk management and epidemiology experience * Experience interfacing with health authorities (worldwide), institutional review boards...
Tags for this Online Resume: Oncology, Protocol, Regulatory Affairs, Risk Assessment, Management, Risk Management, Risk Management Activities, Complaints, Documentation, Hematology, Medical Affairs, Clinical Development
General - 7 Years of Experience
KEY QUALIFICATIONS: * COMPLAINTS & TECHNICAL SUPPORT SPECIALIST WITH 5+ YEARS OF PHARMACEUTICAL AND MEDICAL DEVICE INDUSTRY experience * 5+ years of experience with product complaints including experience with Global Customer Complaints (GCC), adverse events, and auditing of complaint records * Excellent knowledge of quality standards and regulations: FDA QSR 21 CFR 803 & 820, ISO Standards 9001 / 13485 / 14971, MDD 93/42/E...
Tags for this Online Resume: Complaints, Good Clinical Practices, Medical, Pharmaceutical, Support, Technical Support, Clinical Research, Project Management, Project Manager, Research
Medical Transcriptionist
Areas of Expertise * Leveraging 510 (K) PMA and expertise in US, EU, TGA and Canadian medical device regulations. * Manage Kosher/Halal records for ingredients and resale products prepare kosher/Halal applications and registration for products and manufacturing facility. * Knowledge of U.S. FDA medical device regulations (21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807). * Knowledge of ISO 13485, ISO 14971, ISO 9001 and work...
Tags for this Online Resume: Manufacturing, Regulatory Affairs, Test, Advertising, Due Diligence, ISO, Quality Assurance, Compliance, Quality, Quality Control