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Online Resumes with "Regulatory Affairs Professional"
Pharmacist, Regulatory Affairs Professional
Quality Manager - 16 Years of Experience - Near 98012
ACCOMPLISHMENTS Lead teams to achieve fastest clearance times for the Ultrasound business unit outpacing all other Medical Device business units in Philips Regulatory Affairs Professional Society (RAPS) Regulatory Affairs Certified (RAC) American Society for Quality Certified Biomedical Auditor (CBA) ISO 13485:2003, ISO 9001:2000, and ISO 14001:2004 Lead Auditor Certified Implemented Japanese Ministerial Ordinance No.169. A...
Tags for this Online Resume: Quality System, Regulatory Affairs, Compliance, Clinicals, ASQ Biomedical Auditor, RAC, ISO13485, Risk
Biostatatician
SUMMARY Accomplished and result-driven Quality and Regulatory Affairs professional with 15 years of experience in the Medical device and Drug industry, along with over 17 years of leadership, project management and process improvement (Six Sigma or lean manufacturing). ACCOMPLISHMENTS * Developed, implemented and managed quality systems in GMP and GCP settings based on FDA, ISO, MDD, CMDR, ICH, and IEC regulations and guida...
Tags for this Online Resume: Training, Cardiovascular, CT, Documentation, Imaging, Magnetic Resonance Imaging (MRI), Management, Medical
Global Regulatory Affairs - 14 Years of Experience- New Delhi India 110021
Seeking assignments as a Global Regulatory Affairs Professional - NCEs, GENERICS- Pharma, Biotech products, Botanicals & Medical Devices in Global Regions and/or Quality & Compliance professional across the Pharma & Medical Devices Industry. Overall Profile * With overall 15+ years industrial experience, with 14+ years in the field of Global Regulatory Affairs, Compilation & Submissions of Technical Packages for IND/CTA, ND...
Ideal Companies: BBraun Medical Pvt Ltd, New Delhi, India, Glenmark Pharmaceuticals Ltd., Mumbai, India, Panacea Biotec Ltd., New Delhi, India
Tags for this Online Resume: Regulatory Affairs, Management, Medical Devices, Pharmaceutical Industry, IND/CTA, Formulations & APIs, Regulatory Audits & Compliances, NCEs/NMEs/Generics, CT, Regulatory Consultancy, Regulatory Due Diligence & Gap Assessment
Auditor - 13 Years of Experience - Near 33983
SUMMARY: Accomplished pharmaceutical and medical device regulatory affairs professional with a passion for implementing successful strategies to support organizational goals. LICENSED REAL ESTATE SALES ASSOCIATE - For three years I worked out of Industry but continued surveillance of my professional career in Regulatory Affairs. The Real Estate companies I worked for kept me challenged while my husband regained his health. ...
Tags for this Online Resume: Cancer, Manufacturing, Hematology, Immunology, Medical, Pathology, Pharmaceutical, Banking Industry, Chemistry, Integrated Development Environments
Quality Engineer - 20 Years of Experience - Near 84124
SUMMARY An analytical, detail-oriented, and highly motivated senior quality assurance regulatory affairs professional with broad experience globally in quality assurance, strategic planning, auditing, implementations, policies and procedures, compliance, systems management, project management, data analysis, and reporting. Additional aptitude in quality control, process improvement, presentations, and data management. Displ...
Tags for this Online Resume: Audit, Applications, Automotive, Database, Database Applications, Help Desk, ISO, ISO 9001, Management, Quality Assurance
DIRECTOR OF BUSINESS / OPERATIONAL EXCELLENCE: certified Lean/Six Sigma, Design for Six Sigma Master Black Belt
A highly motivated, results-oriented business management professional with proven success in breakthrough process improvements tied to key business priorities and initiatives.
Tags for this Online Resume: Six Sigma, Operations, Manufacture, Continuous Improvement, Management, Process Improvements, Marketing Management, Product Marketing, TQM (Total Quality Management), Lean
Clinical Regulatory Affairs - 0 Years of Experience
Skilled medical device regulatory affairs professional with extensive experience in quality assurance and clinical trial management, including Class III implantables and PMA devices. Six years with the FDA's Office of Device Evaluation. * Domestic and international regulatory affairs experience with a wide variety of devices ranging from disposables to Class III implants * Experienced in Quality System development
Tags for this Online Resume: Management, Consulting, Quality, Quality Assurance, Quality Management, Surgical, Test, Regulatory Affairs, Advertising, Assessments