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Online Resumes with "Manager Regulatory Affairs"



Manager, Regulatory Affairs

Chief Operations Officer - 17 Years of Experience - Near 33306

Strategic thinker with strong sales orientation and solid track record for creating revenue growth, increased profits, and market dominance for both high-growth start-up enterprises and multi-billion dollar global businesses. Proven success spans both corporate and entrepreneurial endeavors. Multidimensional background combines, technical background, strength in sales/marketing, general management, product management, regul...

Tags for this Online Resume: Ft Lauderdale, Miami, Portfolio Prioritization, Startup, High growth, Business Development, Conflict resolution

Clinical Research Coordinator

Position in clinical research management or regulatory affairs in pharmaceuticals or Contracting Research Organizations that offers growth and advancement domestic and internationally specially but not exclusively in South America or Sub-Sahara Africa, implementing, managing and monitoring health policies or clinical drug trials from phases I to IV, targeting infectious diseases and vaccine development, especially for malar...

Featured Profile

Engineer - 20 Years of Experience - Near 84660

I am a dedicated, reliable, experienced quality professional. I have thrived in a variety of roles such as quality engineer, quality management, regulatory affairs, Technical Writer, Internal/External/3rd party audits as well as MRB Chairman, supplier audits/control, Receiving Inspection and machine shop roles. My passion is to make a differance. Using my experience to document or enhanse quality management systems is m...

Tags for this Online Resume: Salt Lake County, Utah County, Quality Engineer, Quality Manager, Technical Writer, Medical Device, Supplier Engineer, Certified Auditor, CTQ Measure and Resolve, Management Review, Natural Leader, ISO 13485, ISO 9001, 21 CFR Section 820, 21 CFR Section 211, Machine Shop, QA Inspection Manager

Senior Manager / Director of Quality

Summary of Qualifications: * Twenty Eight +, years of experience in molecular biology, protein chemistry, biotechnology sciences, QC management, Regulatory Affairs, and Quality Assurance. * Experienced in establishing and directing groups, project management, assay development, personnel training and supervision, quality control, and regulatory cGMPs. * This combination of skills affords a unique opportunity to guide the Qu...

Tags for this Online Resume: Audit, Compliance, Biotechnology, Due Diligence, Licensing, Insurance, Microbiology, Benefits, Documentation, Chemistry

Clinical Regulatory Affairs

Summary of Qualifications: Dedicated Project Management, Regulatory Affairs, and Quality Assurance Professional with global experience working in a regulated environment. Proficient at interacting across numerous functional areas and with all levels of Management. Knowledgeable in global regulatory processes, strategies, and requirements. Capable of seeing multiple complex projects through to successful outcomes. Excellent ...

Tags for this Online Resume: Management, Project Management, Regulatory Affairs, Corrective Actions, Pharmaceutical, Audit, Quality Assurance, Illinois

Business Development Manager

Career Summary: * Over thirty years of experience in multiple aspects of the energy industry ranging from sales to project management to regulatory affairs and more, with proven strong leadership, innovative thinking and, problem solving and multi-tasking skills.

Tags for this Online Resume: Regulatory Affairs, Management, Policies and Procedures, Project Management, Project Manager, Property Management, Utilities

Featured Profile

Clinical Regulatory Affairs - 20 Years of Experience - Near 53143

Summary 30 plus years in the Medical Device and Pharmaceutical industry. Extensive expertise in Supply Chain, Customs Compliance (import and export), Test methods and Process Validations, Technical product development and support, GTIN and UDID process for organizations that meet GS1 standards. Experience in Customs Compliance and Quality Systems Regulations as well as domestic and international standards. Core competencies...

Tags for this Online Resume: Customs Compliance, Scrum Master, Regulatory Affairs, Validation, HR, Quality, Compliance, Hepatitis, Planning, Quality Assurance, Project Manager, Medical devices

Quality Coordinator

Summary of Qualifications: Dedicated Project Management, Regulatory Affairs, and Quality Assurance Professional with global experience working in a regulated environment. Proficient at interacting across numerous functional areas and with all levels of Management. Knowledgeable in global processes, strategies, and requirements. Capable of seeing multiple complex projects through to successful outcomes. Excellent verbal and ...

Ideal Companies: Astellas, Retail, Manager

Tags for this Online Resume: Management, Pharmaceutical, Project Management, Regulatory Affairs, Corrective Actions, Diagnostics, Audit, Project Manager, Quality Assurance, Test

Director of Quality - 20 Years of Experience - Near 91709

SUMMARY OF QUALIFICATIONS * Over twenty years of experience managing regulatory affairs (RA)/quality assurance (QA), quality control (QC)/research & development (R&D) departments in pharmaceutical, medical device and dietary supplement manufacturing industries. Implemented Quality Management Systems meeting domestic and international regulatory requirements and ISO registration. Reviewed pre-clinical, clinical and pharmacok...

Ideal Companies: Pharmaceutical, Medical Device, Biomedical

Tags for this Online Resume: Quality, Quality Assurance, Quality Control, Manufacturing, Regulatory Affairs, Microbiological Testing, Test, ISO, Pharmaceutical, ADA

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

Compliance Manager

Tags for this Online Resume: Health Care Industry, Reviews, Test, Compliance, Management, Regulatory Affairs, Pharmaceutical Industry, Project Management, Project Manager, Siemens