CV, Curriculum Vitae and Online Resumes Search

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Online Resumes with "FDA Regulations"

Clinical Research - 7 Years of Experience - Near 77449

Experienced professional seeking to fill a challenging career with a company willing to utilize my clinical, medical, and management skills.

Tags for this Online Resume: Research Manager, Good Clinical Practice GCP, Clinical Research Coordinator, IRB, Clinical Trials, FDA Regulations, Patient Care, Protocol, Assessments, Clinical Research

Production Manager - 10 Years of Experience - Near 92656

Career Summary: * Working knowledge of FDA regulations, ISO standards, with the understanding of engineering disciplines and manufacturing. * Specializing in company Quality Management Systems (QMS). Revising the current document management systems and setting up new company wide Document Control Systems from the ground floor and up. * Design Mechanical, Electrical, Printed Circuit Boards and cables. With the ability to und...

Tags for this Online Resume: Quality, Document Control, Engineering, Management, Product Development, Support, Autocad, Autodesk AutoCAD, Baan, CAT

Quality Assurance Director - 13 Years of Experience - Near 60453

SUMMARY * 17 years of experience in pharmaceutical, Medical Devices, and FDA regulated environment including Quality Assurance and Process Computer System Validation. * Experience in generating all validation documents, including Validation Plan (MVP), Gap Analysis, Design Specifications, IQ, OQ, and PQ Test Protocols, Standard Operating Procedures (SOPs), and Validation Summary Reports. * Experience in Manufacturing Proces...

Tags for this Online Resume: Compliance, Manufacturing, ISO, Filing, Management, MDR, Process Improvement, Quality, Quality Assurance, Quality Management

Quality Assurance Specialist - 13 Years of Experience - Near 94506

SUMMARY Proficient in developing and applying Software Quality Assurance techniques and strategies to resolve problems in software and compliance with FDA regulation and ISO guidelines in Agile software development environments. Applied SQA principles and methodologies in Manual and Automated Testing with Real Time instruments. Tested instruments Firmware and Drivers. Created, modified and executed test plan and test cases....

Tags for this Online Resume: Real Time Instruments, Test Case Development, FDA, ISO standards, Visual Studio Test Management, Manual and Automated Test, Agile software development, TFS, TestTrack, C#, Python, Troubleshooting, Medical Devices Firmware, Drivers, 21CFR Part 11, Life Science, Data Analysis

Medical Scientist - 2 Years of Experience - Near 55369

Summary of Key Qualifications I am a highly motivated, independent scientist with a wide range of scientific and clinical interests. I can offer: (1) experience in industrial collaboration and working with key stakeholders in academia and industry, (2) an understanding of the drug development process and FDA regulations for MSLs, (3) 10+ years of scientific training, with flexibility across different therapeutic areas (e.g....

Tags for this Online Resume: MSL, Medical Science Liaison, Medical Affairs, KOL, Biotech, Pharmaceutical, Communication, Teaching, Networking, Project Management, Independent, Cell Biology, Oncology, Neurology, Cardiology, Gastroenterology, Endocrinology, Northwest, California, Midwest, United States, Northeast, Field, Travel, FDA, off-label, business acumen

Production Manager - 9 Years of Experience - Near 55379

Profile opportunities and resources for manufacturing organizations. Drive business and profit growth while designing and directing high-impact strategic plans. Generate new revenue streams along with coordinating cross-functional teams to create state-of-the-art products and services. Recognized for excellence in business development and project management, with a proven track record in identifying and implementing process...

Tags for this Online Resume: Business Strategies, Management, Painter, Payroll, Project Management, Manufacturing, Scheduling, Services, Business Development, Control Systems

Clinical Regulatory Affairs - 5 Years of Experience

Profile Regulatory Affairs Specialist with more than five years of experience in the pharmaceutical and biotechnology industries, implementing global regulatory filing strategies. Education in biotechnical engineering with deep knowledge and practical skills in managing the submission process from start to end, monitoring and tracking information, communicating with colleagues, managers and subject experts for efficiency an...

Tags for this Online Resume: Manufacturing, Packaging, Pharmaceutical, Regulatory Affairs, Biotechnical, Filing, Management, Medical, Medical Devices, Microsoft Office

Business Analyst

SUMMARY Over 6 years of experience as a Business Systems Analyst in Pharmaceutical and Medical Devices industries with comprehensive understanding of GxP Regulations. Good understanding of various System Life Cycle models, Waterfall and Agile methodologies. Participated in all phases from analysis, design, and development through testing, implementation and change control. Experienced and proven ability acting as liaison be...

Tags for this Online Resume: ACD, Applications, Asset Liability Management, Asset Management, Automatic Call Distribution, Benefits, Business Analysis, Business Analyst, Business Requirements, CFR Part 11

Quality Coordinator - 10 Years of Experience - Near 08817

SUMMARY Highly knowledgeable and effective Operations professional with diverse industry knowledge and talent for searching out opportunities for improvement, contributing to cost reduction, increased productivity, and waste reduction. Excellent project management skills and strong track record of hiring and successfully developing team members. * Significant success in start-up and high growth operations, laying the ground...

Tags for this Online Resume: Engineering, Fabrication, Industrial Engineering, Support, Technical Support, Complaints, Logistics, P&L, Packaging, Project Management

Plant Manager

CAREER SUMMARY A proven leader and change agent with over 30 years of experience in Manufacturing, Distribution, Engineering, Metal Fabrication, Welding, Assembly, Consumer Goods, FDA Regulated Products, Chemical, Food, and Beverage Industries. Expertise in international travel, operational efficiencies, system layouts, continuous process improvement, plant startups, building strong teams and growing leaders. A concentratio...

Tags for this Online Resume: Communication Skills, Consumer Goods, Consumer Products, Distribution, Engineering, Fabrication, Good Manufacturing Practices, Lean Manufacturing, Light Emitting Diode, Management

Clinical Pharmacovigilance/Drug Safety

SUMMARY * Health care professional with extensive years of experience with Pharmaceutical/Medical device industries as Medical coding and Pharmacovigilance professional in the processing and medical review/evaluation of reports related to investigational and marketed products in the following therapeutic areas: Oncology, Neurosciences, Cardiovascular, Pain/Inflammation, Rheumatology and Diagnostic products. * Responsible fo...

Tags for this Online Resume: Management, Process Improvement, Coding, Regulatory Reporting, Audit, Cardiology, Compliance, Metrics, Oncology, Data Entry

Biomedical Engineer - 6 Years of Experience - Near 76248

Exposure clinical procedures Tech University Ruston, Louisiana * Design of an at home ear irrigation device that manage cerumen impaction * Worked with and Ear, Nose and Throat physician to develop product specifications and testing strategies * Integrated ISO standards, FDA regulations and CPT codes related to diseases state * Hands-on experience with patient diagnosis * Completes projects by assisting project team attendi...

Tags for this Online Resume: Biomedical Industry, Management, Manufacturing, Medical, Troubleshooting, Administrative Assistant, C++ Programming Language, Diagnostic Tools, Integrate, ISO, project manager, mechanical engineering