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Online Resumes with "International Regulatory"
Quality Assurance Specialist - 10 Years of Experience - Near 08817
Project Summary: ARISg is a Drug Safety System which provides all the functionality required to manage adverse event reporting and adverse reaction requirements of different authorities around the world, from case entry to automatic generation of submission ready adverse event (AE) reports including CIOMS I, Med Watch 3500A and many more. ARISg is an automated distributed system. In this system data would transfer to variou...
Tags for this Online Resume: Test, Regression Testing, Management, QTP, Test Scripts, Business Requirements, Framework, Coding, Functional Testing, Java Programming Language
Microbiologist - 20 Years of Experience - Near 80503
Summary Experienced, Self-motivated and Results-Oriented Quality professional with >25 years in the biotech/pharma and medical device industries. Experience hosting FDA and international regulatory agencies. In depth knowledge of compliance to 21 CFR parts 210 and 211, 21 CFR Part 11, 21 CFR part 820, ISO 13485, ICH Q1A-F, Q7, Q8, Q9, Q10, USP, EP, JP Testing. Knowledge and experience with GxP auditing. Chemical and Microbi...
Tags for this Online Resume: Validation, Lab Management, QMS, Compliance, Pharmaceutical, DS, DP, Research and Development, Microbiology, Manufacturing
Regulatory Affairs
Tags for this Online Resume: Regulatory Affairs, Registration of products, International Regulatory Agencies
Regulatory Affairs, Quality, and Clinical Evaluation Consultant to Medical Device Industry
PROFESSIONAL PROFILE: A focused, driven, and passionate regulatory affairs and quality/compliance/auditing consultant with hands-on experience in RA and Quality/Compliance/Auditing associated with activities which lead to, and maintain regulatory approval to ISO 13485, FDA 510 (k), EU CE Mark & other international market authorizations of medical device products and conformance/compliance of Quality Management Systems. Regu...
Tags for this Online Resume: Management, Regulatory Affairs, Assessments, Audit, Budgeting, ISO, Microsoft Office, Quality, Quality Assurance, Quality Management, oncology, protocol, 13485, FDA, 483, Warning Letter, Portuguese, Spanish, ANVISA, Lead Auditor, Quality Systems, Quality Audit, Medical Device
Not Listed - 20 Years of Experience - Near 48042
Areas of Expertise Security + Safety Leadership + Risk + Threat Assessment Mitigation Strategies + Problem Solving Savant Executive Law Enforcement Liaison Domestic / International + Regulatory Expertise Crisis + Venue Operational Management Strategic + Field Operations + Fiscally Sound Business Acumen Continuity of Operations + Critical Thinking Exceptional Oral and Written Communication Skills + Media + HR Expertise Colla...
Tags for this Online Resume: Human Resources, Management, SAS, Security, Policies and Procedures, Program Manager, Public Relations, Research, Social Media, security, investigations, training, hiring
Federal Government - 20 Years of Experience - Near 48042
Areas of Expertise Security + Safety Leadership + Risk + Threat Assessment Mitigation Strategies + Problem Solving Savant Executive Law Enforcement Liaison Domestic / International + Regulatory Expertise Crisis + Venue Operational Management Strategic + Field Operations + Fiscally Sound Business Acumen Continuity of Operations + Critical Thinking Exceptional Oral and Written Communication Skills + Media + HR Expertise Colla...
Tags for this Online Resume: Human Resources, Management, SAS, Security, Physical Security, Policies and Procedures, Program Manager, Public Relations, Research, Social Media
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
Program Manager
Inform and educate prospects, train internal personnel on products and services. Develop products and process improvements. Create solutions to increase sales and profitability.
Ideal Companies: Alcon, PACCAR, Textron, Westinghouse, GE
Tags for this Online Resume: Project, Program, Engineer, Manager, Lean, Design, Process, Team, IT, Change, Lead, Instructional, Training, Development, Business, Research, Improvement
Senior Counsel/Compliance Counsel Mortgage Industry - Compliance Counsel/Financial Services - 20+ Years Experience
Stripped down to its core, my "Career Objective" is to maintain - through those policies and procedures I have created - a clear understanding that upholding a viable "culture of regulatory compliance" does NOT automatically equate to a loss of business or operational interference.
Tags for this Online Resume: Compliance, Consulting, Litigation, Financial Industry, counsel, Complaints, general counsel, chief compliance officer, Policies and Procedures, Financial, Senior Counsel, strategist, regulatory compliance, Dodd-Frank, Privacy/Reg B
Network Security Engineer - 14 Years of Experience - Near 23228
SUMMARY An Information Security Professional with proven experience in Risk Management Framework (RMF), Systems Development Life Cycle (SDLC), and Risk Assessment using industry frameworks such as OMB, FISMA, Health Insurance Portability and Accountability Acts (HIPAA), and applicable NIST special publications. Other areas of proficiencies include Customer Relation Management, Emotional Intelligent competencies and Team Bui...
Tags for this Online Resume: Security, System Security, Connectivity, Nessus, Troubleshooting, Assessments, Information Security, Monitoring, Sar, Systems Security
Senior Counsel-Corporate and Regulatory Compliance - 20 Years of Experience - Near 11023
As a highly qualified and experienced financial services regulatory attorney specializing in the insurance and reinsurance field, both life and property/casualty, and as a practice team leader in my two most recent law firms, I demonstrate exceptional knowledge of federal, state and international regulatory and compliance issues, transactional acumen, client and employer loyalty, reliability, power of endurance and leaders...
Ideal Companies: Allied World, Swiss Re, Hiscox, XLCatlin, Arch Insurance, Chubb, MetLife, Berkshire Hathaway, Markel, QBE Insurance
Tags for this Online Resume: Acquisitions, Licensing, Mergers, Mergers and Acquisitions, Futures, Securities, Equity, Compliance, Commodities, Management
Arbitrator, Mediator or Conciliator - 8 Years of Experience - Near 20707
SUMMARY OF QUALIFICATIONS * A multi award recognized internationally distinguished attorney with self- motivated and innovative skills. * Local and international Arbitration and dispute resolution expert. * I am endowed with an excellent human resource concept in Trial advocacy Corporate Law, Major transaction Contracts Compliance Administration, Strategy, Planning and Risk Management. * Interest areas are Legal Advocacy an...
Tags for this Online Resume: Compliance, Management, Fraud, Litigation, Arbitration, Drafting, Due Diligence, Financial, Risk Management, Audit
