James Kuhn

James Kuhn Email and Phone Number

Philadelphia, PA, US
James Kuhn's Location
Greater Philadelphia, United States, United States
James Kuhn's Contact Details

James Kuhn personal email

n/a
About James Kuhn

James Kuhn is a Regulatory Affairs at Global Regulatory Press (Journal of Medical Device Regulation). He possess expertise in fda, quality system, medical devices, regulatory affairs, quality assurance and 13 more skills. Colleagues describe him as "Jim is an extremely diligent and talented colleague. He possesses that hard to find combination of solid analytical as well as excellent written communication skills that are so critical in the development of regulatory submissions. I highly recommend Jim's work!", "Without a doubt, Jim is one of the most knowledgeable professionals in quality assurance and regulatory compliance that I have ever had the pleasure of having on the team. He is results focused with a keen eye for navigating a compliant and expeditious route to full Quality Assurance, CE Mark authorization and FDA PMA approval. Jim has always completed projects on time, under budget and to executive management expectation. He possesses impeccable integrity and preserves the utmost trust with confidential information. The value of Jim's expertise in gaining approvals and certifications certainly exceeds the cost and time of realizing these goals without him. I highly recommend Jim to any employer in need of a regulatory and/or quality professional in the US and European Medical Device Markets. -Joseph C. Griffin, III", and "Jim is an outstanding quality and regulatory manager and one of the most ethical and conscientious professionals that I have ever worked with. He is extremely knowledgeable in quality system management and regulatory affairs and is well respected by FDA. He is intelligent, hard working, and extremely detail oriented. Jim is also an excellent manager and team leader who motivates his subordinates with respect and guidance. I highly recommend Jim for any senior level quality or regulatory management position."

James Kuhn's Current Company Details
Global Regulatory Press (Journal of Medical Device Regulation)

Global Regulatory Press (Journal Of Medical Device Regulation)

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Regulatory Affairs
Philadelphia, PA, US
James Kuhn Work Experience Details
  • Global Regulatory Press (Journal Of Medical Device Regulation)
    Global Regulatory Press (Journal Of Medical Device Regulation)
    Philadelphia, Pa, Us
  • Global Regulatory Press (Journal Of Medical Device Regulation)
    Editorial Advisory Board Member
    Global Regulatory Press (Journal Of Medical Device Regulation) Aug 2007 - Present
    Member of Editorial Staff
  • Rowan University
    Adjunct Professor
    Rowan University Sep 2017 - Present
    Glassboro, Nj, Us
    -Teaching (Part-Time) Regulatory Affairs in Biomedical Engineering Program
  • Animas (Johnson & Johnson Company)
    Regulatory Affairs Manager
    Animas (Johnson & Johnson Company) Feb 2016 - Aug 2020
    510k Submissions, PMA Supplements, International Product Registrations, Process Improvements, CE Marking, Device Classifications, Regulatory Strategies
  • Siemens Medical Solutions
    Senior Regulatory Affairs Submissions Manager
    Siemens Medical Solutions Mar 2006 - Feb 2016
    Forchheim, De
    include;- PMA, 510k, CE marking, international product registration, device classifications, product licenses, device listings- Clinical evaluations, labeling review, non-filing justifications, complaint handling, recalls, translations, export control- Regulatory strategies, direct interface with regulatory agencies, file management, training, auditing
  • Ep Medsystems Inc
    Director Of Quality Assurance / Regulatory Affairs
    Ep Medsystems Inc Sep 1996 - Dec 2005
    Included;-Development and maintenance of cGMP (QSR) / ISO / CE Mark compliant Quality System for a Class III Device-Employee training, internal /vendor audits, Validations, Complaints Handling, and Risk/Hazard Analysis-510k, IDE, PMA, Design Dossier development and submissions to appropriate regulatory bodies.-Direct International Product Registrations, approvals, and clinical trials.-Manage and direct the staff efforts for QC/QA, Document Control, and Regulatory Affairs personnel.Summary of Proven Accomplishments;Development and effective implementation of a cGMP/ISO13485/MDD Compliant QA SystemVarious Class III Medical Device Approvals and Supplements for both FDA (510k) and CE MarkDirected Modular PMA #990069 Approval - ALERT System, November 27th, 2002Directed successful completion and closure of multiple FDA cGMP and European CE Audits
  • Silver Cloud Manufacturing
    Quality Assurance Manager
    Silver Cloud Manufacturing Dec 1994 - Sep 1996
    Responsibilities included:-Development of ISO 9000 documentation, quality system, internal and external audits, employee training, SPC-ISO Coordinator for New Jersey ISO Small Business Consortium Program.-Implementation of Total Quality Program throughout the organization.-Development of Vendor Audit / Qualifications program
  • Machine Designers Inc
    Engineer\Technical Writer
    Machine Designers Inc Aug 1991 - Dec 1994
    Responsibilities included: - Providing Project Management and designs with CAD.- Technical publications for manufacturing processes and equipment.- Creation of internal policies and procedures using ISO 9001 standard.- Project costing\scheduling\requirement analysis.- Quality system development and implementation
  • Plasma-Therm
    Engineering\Design Manager
    Plasma-Therm Feb 1980 - May 1991
    St. Petersburg, Fl, Us
    Responsibilities included:- Providing technical assistance to Designers and Draftsman.- Implementation, training, and maintenance of CAD System\computers.- Accuracy and completion of all project documentation.- Hiring, training, motivating, disciplining, and scheduling of all subordinates.- Developed documentation, specifications and manufacturing procedures for all systems.

James Kuhn Skills

Fda Quality System Medical Devices Regulatory Affairs Quality Assurance Iso 13485 Gmp Ce Marking Capa V&v Design Control Cross Functional Team Leadership Iso 14971 Healthcare Information Technology Healthcare Business Process Improvement Corrective And Preventive Action Hardware Diagnostics

James Kuhn Education Details

  • The George Washington University
    The George Washington University
    Corporate Healthcare Compliance
  • Rowan University
    Rowan University
    Industrial Engineering/Technology
  • Camden County College
    Camden County College
    Engineering

Frequently Asked Questions about James Kuhn

What company does James Kuhn work for?

James Kuhn works for Global Regulatory Press (Journal Of Medical Device Regulation)

What is James Kuhn's role at the current company?

James Kuhn's current role is Regulatory Affairs.

What is James Kuhn's email address?

James Kuhn's email address is ja****@****mas.com

What schools did James Kuhn attend?

James Kuhn attended The George Washington University, Rowan University, Camden County College.

What skills is James Kuhn known for?

James Kuhn has skills like Fda, Quality System, Medical Devices, Regulatory Affairs, Quality Assurance, Iso 13485, Gmp, Ce Marking, Capa, V&v, Design Control, Cross Functional Team Leadership.

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