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Online Resumes with "510 k "
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 years’ 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...
Tags for this Online Resume: Voice of Customer, P&L Management, New Product Development, Upstream / Downstream Marketing, Employee Development, Leader of Cross Functional Teams
Goal focused Quality Leader in medical devices and pharmaceuticals
Began career with 10 years with the FDA in the Detroit District office and at the Kalamazoo, MI and Grand Rapids Resident Posts. Conducted inspections at pharmaceutical and medical device companies, conducted investigations and testified in court. I Left for a start-up medical device contract manufacturer where I developed the quality system and initiated 510(k) submissions. I also identified and resolved problems result...
Ideal Companies: Small to large medical device or pharmaceutical companies such as Abbott Laboratories, Baxter, CR Bard, Phillips, Medtronic, Boston Scientific, St. Jude Medical, Johnson & Johnson, Bausch and Lomb.
Tags for this Online Resume: Quality Systems Management, Regulatory Compliance, ISO 9001:2000/ISO 13485:2003, Pharmaceutical GMPs
Clinical Regulatory Affairs
Tags for this Online Resume: regulatory affairs, quality assurance, clinical research associate, cGMP compliance, ISO 13485, NDA, IND, 510K, PMA, SOP, quality audit
QA Manager, document Control
I have over 30 years of experience in the medical device, pharmaceutical, and biologics experience with a strong background in Class III Medical Device Safety and pharmaceutical quality and compliance. My management background included coordinating inspection assignments, managing investigation activities and assigning investigation tasks to all involved departments, preparing summary reports, reporting metrics for complain...
Medical Device Engineer
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.
Tags for this Online Resume: Biomedical Engineer, Finite Element Analysis, Cardiovascular Disease, Medical Device, Mechanical Engineering , AutoCAD, ISO 13485, FDA 510K, Product Development
Director, R&D - 18 years experience in medical device design and development
An experienced Engineering Director seeking a senior technical/project management position at an emerging or established medical device company in or around Tempe, AZ.
Tags for this Online Resume: Medical Devices, Design and Development, Program and Project Management, FDA Regulatory, 510(k), Technical File, CE marking, Cross Functional Team Leadership
Aerospace Engineer
Tags for this Online Resume: Manufacturing Production engineer, Continuos Flowmanufacturing, mass production , New Product Development, IQ, OQ, Validation, Design Of Experiment DOE, 510K, PMA, FDA, 510K, PMA, FDA Medical Devices
Product Development Manager
Highly effective educator with excellent communication and organizational skills.
Ideal Companies: Johnson and Johnson, Merck, Medtronic, Wyeth
Tags for this Online Resume: Business Development, Education, Training, Education Director
R&D Team Leader
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.
Tags for this Online Resume: Molecular Diagnostics IVD, LDT & CLIA, New Product Development, Microarrays, FDA 510K, RT-PCR
Experienced Validation/Product Development, Investigation Manager (Medical Devices)
To be an active participant in the validation, product development/launch, product improvement, product investigation, product compliance of a medical device or biotechnology related item.
Ideal Companies: Johnson & Johnson, Pfizer, Roche, Abbott, Battelle, University of Virginia
Tags for this Online Resume: Validation, CAPA investigations, FDA regulated devices, Product Development, FMECA, Manager, Failure Investigations, Data analysis, Plan/Report writing, Process Excellence, Project Management, Policy Development, Procedure Development, Medical Diagnostic Devices
The Sushmita Sen of Regulatory Affairs
Ideal Companies: Abbott, GE Medical, Pfizer, Roche, Beyer
Tags for this Online Resume: regulatory, global regulatory, Regulatory Affairs, compliance, clinical affairs
DIRECTOR OF ALGORITHM / SOFTWARE DEVELOPMENT
Outstanding senior R&D leader in imaging algorithm/software development and advanced technology for the medical device industry, with over 18 years of experience as the head of key programs in different business units and companies. Demonstrated track record of driving advancements in technology development to ensure competitive market positioning and capture strong customer share. Dedicated to introducing the latest in eme...
Ideal Companies: Varian medical systems, Ventana medical systems, Boston scientific, BD biosciences, Abbott,
Tags for this Online Resume: Algorithm Development, Software Development, System Management, Project Management, Product Release, C, Java, GPU, .NET, C#, Sustaining Engineering, Advanced Development, Multiple Site Management
