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Online Resumes with "FDA 510K"
I am known as a volume producer; task orientated, detailed and very organized who readily adapts to rapidly changing priorities.
I am experienced in the fields of Documentation and Change Control Systems, Design Controls/Audits and Risk Assessment Analysis / Management, Project Leader, Accounting, and Data Processing.
Ideal Companies: Stable
I Seek a fulltime Regulatory Affairs professional position that will utilize the achievements, skills, strategic thinking and leadership abilities that enable me to aid the company in timely submission packets; Wereby we consistently exceed earnings potentials and achieve company goals in any of today's global economic markets.
Senior Marketing and Sales Professional - 10 years expierience - VOC, Stage-Gate, CRM, P&L Management, Strategic Planning
Accomplished, decisive, and knowledgeable Sales and Marketing executive with over 10 yearsβ experience in innovative, profit oriented business. Recognized for building strong brands using integrated marketing methodologies. Key contributor to strategic business planning with experience leading, managing, and developing long-range growth plans. Respected as a dynamic team leader and creative solutions provider. Demonstra...
I am interested in and trained to work for medical device companies. I have excellent experiences investigating medical devices by using finite element analysis. From original drawing of the device, simulations will be carried out to propose possible modifications to optimize the design.
My career objective is to lead a new product development project in molecular diagnostics leading to the development of IVD kit. I would like to use cutting edge technology such as microarray, genotyping and next generation sequencing to advance the cause of personalized medicine.
top-performing healthcare professional, with strong expertise in performance of FDA 510K certified medical equipment management, repair and maintenance. Certified in clinical hemodialysis, water purification and hemodialysis technology. Highly accomplished in technical education; staff development, CQI principles and quality assurance. Ensure compliance with all federal, state and company regulations, policies and procedur...
Ideal Companies: Fresenius Medical Care; Kaiser Permanente; Providence Health & Services; Legacy Health System; Intel; State of Oregon; City of Portland, OR; Multnomah County, OR; Clackamas County, OR;
Tags for this Online Resume: Healthcare, Biomedical, Water Treatment, Hemodialysis, Quality Assurance, Repair, Maintenance, Customer Service, Technical Writing, Technical Education, Staff Development, Regulatory Compliancce, Inventory, MS Office, Water Microbiology, Patient Care, OSHA Regulations
Summary of Qualifications: Scientist with 20+ years of combined experience within the In-Vitro Diagnostics Devices and Biotech Industries with success as a Bench Scientist in completing a project ahead of time, and co-authoring a report which resulted in a 3 million bonus for Gen Probe.
Tags for this Online Resume: In-Vitro Diagnostics Medical Devices, Regulatory Affairs, Scientific Writing, Annual Reports, Research, Manufacturing, Troubleshooting, Pre-Sub, FDA, 510(k), PMA, Experimental Design, Monoclonal Antibodies, Medical Devices, Nucleic Acid Amplification, End-Point/Real-Time PCR, qPCR
Qualifications include: 19 years experience in medical device/pharma fields. 7 years experience in other industries including semiconductor mfg. and marine engineering. Team member of 3 successful medical device companies through start-up, acquisition and integration. Broad experience operating a medical device business to include: R&D, engineering, manufacturing, regulatory, QAQC, operations, finance, and sales and marketi...
SUMMARY: Hands-on, Multidisciplinary Design Engineer with Project Management and NPI/NPD experience. Electrical, Mechanical, Electromechanical, Controls, Process, and Lean Manufacturing Systems Design, Development, Commissioning and Optimization. * Purpose Built Machinery Design, Development, and Automation for Manufacturing, Assembly, Packaging and Test. Design Specification to Installation and Commissioning, IQ/OQ/PQ (Pro...
QUALIFICATIONS * Creating High-Performance Teams * FDA 510k Process * Operating Leadership - Accountable * Multimillion-Dollar Resource Management * Innovator - Creating Breakout Growth Plans * Technology licensing & Acquisition * Capital Sourcing, M & A, Roll-ups, Bolt-On's * Non-Profit Executive Leadership * Executable GTM Sales & Marketing Strategies * Mobilization, Donor Development * Agile Software Development Environm...
Career Highlights Conducted requirements analysis and user feedback sessions (internal users to members of Congress) and provided summary analysis with recommendations for user experience improvements. Produced next generation site with more intuitive user interface. (Canton Group) Managed successful launch of portal for Audi of America (AoA) by leading requirements gathering, prototyping, client feedback, presenting update...
Tags for this Online Resume: Product Development, Test, Test Plans, Management, Medical, Project Management, Protocol, Troubleshooting, Applications, Cascading Style Sheets, agile, software, html, requirements gathering, QA
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