James Barley

James Barley Email and Phone Number

FDA/ISO Regulatory Affairs & Quality Assurance @
James Barley's Location
Dana Point, California, United States, United States
James Barley's Contact Details
About James Barley

• Proven ability to set-up, organize and implement Quality Assurance Programs in compliance with the FDA’s 21 CFR Part 820, ISO 13485:2016, 21 CFR Part 110 and 111, ISO 9001:2015, MDSAP.• Coordinate the administration, engineering, regulatory and quality assurance efforts for the development of new products.• Develop protocols and coordinate test programs for manufacturing, packaging, sterilization and software validations. • Experienced in the submission of 510(k)’s, Investigational Device Exemptions and Pre-Market Approval Applications to the US FDA as well as product approvals for worldwide distribution.Regulatory Consultant for:ISO and FDA regulatory affairs professionalsISO 13485 and ISO 9001 registration and certification consultantsMedical device development and manufacturing engineersEU CE Mark Medical Device Directive (MDD, IVDD and AIMDD) consultantsFDA GMP regulations, QSR and product validation specialistsFDA and ISO audit advisorsQuality systems and quality assurance (QA/QC) consulting expertsFDA 510k notification/submissions specialistsSpecialties: Medical Devices and Dietary Supplements

James Barley's Current Company Details
Abrimed Consulting Services

Abrimed Consulting Services

FDA/ISO Regulatory Affairs & Quality Assurance
James Barley Work Experience Details
  • Abrimed Consulting Services
    President
    Abrimed Consulting Services 2010 - Present
    Provide Regualtory and Quality Assurance consulting services to small and medium sized companies. Set-up and implement quality systems compliant to the FDA's 21 CFR Part 820, 21 CFR Part 110 and 111, ISO 13485 and ISO 9001. Conduct internal audits for compliance to quality system and assistance with FDA compliance audits.Provide outsourcing opportunities for US Companies. Affiliated with a number of Chineese manufacturers who have extensive experience manufacturing medical devices for major US Companies. In addition, can provide sources for new products from international manufacturers. Assistance with developing Design History Files and Technical Files for the CE Mark including Risk Analysis. Develop the protocols, assist with testing and inspections and write Final Reports for Molding, Packaging, Sterilization and Software Validations.Prepare and submit 510(k)'s, Pre-Market Approval Applications and Investigational Device Exemptions (IDE's).
  • Jb & Associates
    Owner
    Jb & Associates Feb 1992 - Present
    Southern California
    Provide Regualtory and Quality Assurance consulting services to small and medium sized companies. Set-up and implement quality systems compliant to the FDA's Quality System Regulation, ISO 13485 and ISO 9001. Conduct internal audits for compliance to quality system and assistance with FDA compliance audits.Assistance with developing Design History Files and Technical Files for the CE Mark including Risk Analysis. Develop the protocols, assist with testing and inspections and write Final Reports for Molding, Packaging, Sterilization and Software Validations.Prepare and submit 510(k)'s, Pre-Market Approval Applications and Investigational Device Exemptions (IDE's).
  • Inviro Medical
    Director Of Regulatory Affairs & Quality Assurance
    Inviro Medical 2001 - 2010
    Duluth, Ga
    Set up and implemented a quality system compliant with the FDA's Quality System Regulation and ISO 13485:2003. As Management Representative, responsibilities include maintenance of the QMS and Device Master Records for lnviro Medical Devices. Conduct site audits and product inspections in Hungary, China, Korea, Taiwan and Korea. Assisted manufacturers in developing incoming, in-process and final inspection criteria and techniques. Submitted 510(k)'s for safety syringes and needles.
  • Injex-Equidyne Systems Needle-Less Jet Injector System
    Director Of Regulatory Affairs & Quality Assurance
    Injex-Equidyne Systems Needle-Less Jet Injector System 2002 - 2005
    This product is for the injection of medicines and vaccines without a needle. The medication is drawn into an Ampule which includes an Ampule Body and Plunger/Plunger Tip. The Ampule is then screwed into the end of the cocked injector and placed against the user's shin. The trigger is pushed and a high powered spring provides the force to inject the medication into the body without a needle. Filed 510(k)'s Jet Injectors.
  • Applied Diabetes Research Reservoirs And Infusion Sets For Infusion Pumps
    Director Of Regulatory Affairs & Quality Assurance
    Applied Diabetes Research Reservoirs And Infusion Sets For Infusion Pumps 1999 - 2004
    These generic Reservoirs/syringes and infusion sets are compatible with MiniMed infusion pumps for diabetics. The Reservoirs consist of a Barrel and Plunger/Plunger Tip. The users fills the reservoir with insulin, attaches the infusion set and places the reservoir in the infusion pump. The pump then dispenses the medication to the user.
  • Cardiodynamics
    Director Of Regulatory Affairs & Quality Assurance
    Cardiodynamics 1998 - 2003
    Greater San Diego Area
    Worked with the company's R&D Department in the development of Hemodynamics monitoring devices. Filed multiple 510(k)'s on the device. The device consisted of proprietary hardware and software development, integration into existing over the counter hardware and software and electrodes for monitoring patient parameters. The 510(k) consisted of hardware and software validations.
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  • Health Care Products
    Ra/Qa Consultant
    Health Care Products 1997 - 2000
    Pasadena, Ca
    Worked with the company's R&D Department to develop a glucometer using a proprietary membrane to measure the patient's blood sugar level. Developed all verification and validation test protocols and participated in all bench testing which included blood glucose testing and interference testing. Wrote the clinical study protocols, set up and trained the clinical sites, monitored the clinical study and wrote the final report which included a summary of all clinical data. Filed and received marketing clearance from the FDA for the device.
  • International Ophthalmics
    President/Vice President Of Regulatory Affairs/Quality Assurance
    International Ophthalmics 1985 - 1993
    Responsible for the day to day operation of the company including manufacturing, production control, quality assurance, R&D, Finance and administration of this start up company. Reported to the Board of Directors. Developed the protocol, set-up and monitored the 500 subject clinical trial for the Class III device. In addition, participated in the development of the final report. In addition, submitted the Investigational Device Exemption, Annual Reports, Supplemental Report and Pre-Market-Approval Application for the intraocular lenses.

James Barley Skills

R&d Quality System Fda Medical Devices Quality Assurance Iso 13485 Product Development 510k Iso Regulatory Affairs Regulatory Submissions Fda Gmp Internal Audit Clinical Trials Clinical Study Design Risk Management Risk Assessment Iso 9000 Iso 9001 Outsourcing Sourcing Consultants Establishment Registration Medical Device Directive Medical Device R&d Class Ii Medical Devices Medical Device Development Cgmp Manufacturing Cgmp Practices International Approvals International Project Management International Business Consulting Sterilization Start Ups Testing Cross Functional Team Leadership Manufacturing V&v 21 Cfr Product Launch Engineering Ce Marking Continuous Improvement

James Barley Education Details

Frequently Asked Questions about James Barley

What company does James Barley work for?

James Barley works for Abrimed Consulting Services

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

James Barley's current role is FDA/ISO Regulatory Affairs & Quality Assurance.

What is James Barley's email address?

James Barley's email address is ji****@****aol.com

What is James Barley's direct phone number?

James Barley's direct phone number is +194943*****

What schools did James Barley attend?

James Barley attended Pepperdine University, The George L. Graziadio School Of Business And Management, Lowell Technological Institute, Special Courses.

What skills is James Barley known for?

James Barley has skills like R&d, Quality System, Fda, Medical Devices, Quality Assurance, Iso 13485, Product Development, 510k, Iso, Regulatory Affairs, Regulatory Submissions, Fda Gmp.

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