James Kuhn Email and Phone Number
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James Kuhn personal email
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."
Global Regulatory Press (Journal Of Medical Device Regulation)
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Global Regulatory Press (Journal Of Medical Device Regulation)Philadelphia, Pa, Us
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Editorial Advisory Board MemberGlobal Regulatory Press (Journal Of Medical Device Regulation) Aug 2007 - PresentMember of Editorial Staff
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Adjunct ProfessorRowan University Sep 2017 - PresentGlassboro, Nj, Us-Teaching (Part-Time) Regulatory Affairs in Biomedical Engineering Program -
Regulatory Affairs ManagerAnimas (Johnson & Johnson Company) Feb 2016 - Aug 2020510k Submissions, PMA Supplements, International Product Registrations, Process Improvements, CE Marking, Device Classifications, Regulatory Strategies
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Senior Regulatory Affairs Submissions ManagerSiemens Medical Solutions Mar 2006 - Feb 2016Forchheim, Deinclude;- 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 -
Director Of Quality Assurance / Regulatory AffairsEp Medsystems Inc Sep 1996 - Dec 2005Included;-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
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Quality Assurance ManagerSilver Cloud Manufacturing Dec 1994 - Sep 1996Responsibilities 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
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Engineer\Technical WriterMachine Designers Inc Aug 1991 - Dec 1994Responsibilities 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
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Engineering\Design ManagerPlasma-Therm Feb 1980 - May 1991St. Petersburg, Fl, UsResponsibilities 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
James Kuhn Education Details
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The George Washington UniversityCorporate Healthcare Compliance -
Rowan UniversityIndustrial Engineering/Technology -
Camden County CollegeEngineering
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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