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Online Resumes with "510 K "



Experienced Director of Laboratory Operations.

Has ability to see the big picture and place within it. Great ability to find and resolve problems within a process. Enjoys making things work more effeciently.

Ideal Companies: Olympus, Roche, Siemens, Bayer,

Tags for this Online Resume: Manager, Director of operations, Technical support rep, supervisor

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

Tags for this Online Resume: Regulatory Specialist EU, Document Control Manager

Accomplished New Product Development & Quality Assurance Manager

� Accomplished, self-starting New Product Development and Quality Assurance engineering manager � Over 10 years of experience in medical device development � Hands-on experience leading product development cycle from concept selection to commercialization in both New Product Development and Quality Assurance management roles, including voice of customer activities, concept selection, design characterization, verification an...

Ideal Companies: Johnson & Johnson, General Electric, Kimberly Clark

Tags for this Online Resume: Quality, New Product Development, Manager, Medical Device, Biomedical, NPD, Engineer, Research , QA, Development, Quality Assurance

Medical Device Design Engineer - 18 years experience - 510K & Validation Expert

Looking for a contract or full-time position with an innovative Medical Device Company in the Denver area that needs a person with Leadership Experience and Manufacturing background. I can help develop new products on time and on budget with patient safety always the highest priority.

Ideal Companies: Covidien, Caridian BCT, ConMed, etc..

Tags for this Online Resume: SolidWorks , Plastics, Manager, Validation , Manufacturing , Testing, Project , Supply , Verification, Process , Quality , SOP

Partner

I'm an all around type of guy, loves sports, education.Currently in College at the moment.

Ideal Companies: Lacoste, Polo, Aeropostle

Goal-oriented, meticulous, highly organized

not only exceptional technical competency but also superior analysis, problem-solving abilities, leadership, communication and team member experience.

Ideal Companies: Companies that have more than 50 employees and been in business for awhile.

Tags for this Online Resume: sales and marketing, customer service, regulatory affair, research and development, management, sales, development

Regulatory Affairs Specialist

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.

Tags for this Online Resume: Regulatory Affairs Professional, FDA 510(k), PMA, IDE, ICH, CE Markings, EU MDD, CMDCAS

Cell Therapy- Senior Principal R&D Scientist

Dynamic result driven Senior Principal Scientist and leader with a wealth of industrial product development experience and attention to product quality. Excellent analytical testing skills, team building, product improvement planning, mentoring and project management. Seeking a cross-functional position within the Cell Therapy, Tissue Regeneration and Medical Devices industries where an immediate impact can be made

Tags for this Online Resume: Cell Therapy - Stem Cells, Orthopedics, Regulatory Technical files, CE Mark, (510k), Medical devices, Hematology - bone marrow, Tissue regeneration

regulatory affairs associate/specialist

Seeking a position in Regulatory Affairs where my skills, work ethic and achievements will be utilized to the best and which will provide me opportunities for intellectual and professional growth

Tags for this Online Resume: NDA, BLA, 510(K), ANDA, SOPS, PROTOCOLS, IND, PMA, PDP, LABELING , MEDICAL DEVICES, DIAGNOSTICS, IVD, CE MARKING, ICH,GMP,GLP,CBE-30,CBE-0, IB, SPL

Aircraft Rigging Assembler

Tags for this Online Resume: Medical Devices, ISO 13485 AS9100 ISO 9001, FDA 820 510(k), Quality Systems Auditor, Quality Systems Author

Clinical Product Development Professional

As a results-driven professional with expertise spearheading the vision, development, and launch of revenue-producing opportunities in the medical device industry, I am currently looking for my next challenge. I offer exceptional experience in product development, clinical development, regulatory affairs, commercialization, and global launch. With my broad experience and hands-on approach to team building and management, ...

Tags for this Online Resume: clinical, biotech, medtech, operations, medical device, 510k

Medical Technology Executive

As a results-driven professional with expertise spearheading the vision, development, and launch of revenue-producing opportunities in the medical device industry, I am currently looking for my next challenge. I offer exceptional experience in product development, clinical development, regulatory affairs, commercialization, and global launch. With my broad experience and hands-on approach to team building and management, ...

Tags for this Online Resume: Executive, Medical Device, Biotech, Clinical, Regulatory, Operations