Gary Becker

Gary Becker Email and Phone Number

Director Quality Regulatory Affairs @ Aventusoft LLC
Boca Raton, FL, US
Gary Becker's Location
Boca Raton, Florida, United States, United States
Gary Becker's Contact Details
About Gary Becker

Specializing in taking Medical Device companies from startup to compliance. Implement a FDA cGMP and/or ISO 13485 Quality System from scratch. Software expertise (former Software Product Developer Director). ISO 62304, 14971. 510K, MDD, CMDR, CE mark.1) Compliance GAP analysis2) Safety Risk Management, FMEA3) Design Control4) Software Validation5) Audits6) Software Testing7) ISO 13485 via MDSAP*Just got my company certified to ISO 13485 via MDSAP including Canada SOR 98-282Six Sigma Green BeltISO 13485 AuditorASQ & RAPs member

Gary Becker's Current Company Details
Aventusoft LLC

Aventusoft Llc

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Director Quality Regulatory Affairs
Boca Raton, FL, US
Gary Becker Work Experience Details
  • Aventusoft Llc
    Director Quality Regulatory Affairs
    Aventusoft Llc
    Boca Raton, Fl, Us
  • Aventusoft Llc
    Director Quality Regulatory Affairs
    Aventusoft Llc Jul 2023 - Present
    Boca Raton, Florida, Us
  • Canon Medical Systems Usa, Inc.
    Regulatory Affairs Manager
    Canon Medical Systems Usa, Inc. Jan 2020 - May 2023
    Tustin, Ca, Us
    Manager, Regulatory Post Market- Complaints- Recalls- Fda facility registration - Device listing- Field Modifications- MDR- Certified Lead Auditor
  • Virtual Imaging, Inc. A Canon Company
    Quality And Regulatory Manager
    Virtual Imaging, Inc. A Canon Company Jul 2016 - Jan 2020
    Develop Quality System from scratch..Manage the compliance of the Quality System.Responsible for overall Product Quality.Quality Management Representative.FDA and ISO compliance.Software Validation.Complaint Management.CAPA management.MDSAP Certification to ISO13485 , and Canada
  • Mobilehelp
    Director, Quality Assurance
    Mobilehelp Jul 2012 - Jul 2016
    Philadelphia, Pennsylvania, Us
    Develop Quality System from scratch..Manage the compliance of the Quality System.Responsible for overall Product Quality.Quality Management Representative.FDA and ISO compliance.Software Validation.Complaint Management.CAPA management.
  • Philips Healthcare
    Manager, Quality & Regulatory
    Philips Healthcare Jan 2008 - Jul 2012
    Amsterdam, Noord-Holland, Nl
    Manager of Quality and Regulatory. Software Quality AssuranceQuality SystemsFDA & ISO
  • Emergin
    Director, Quality & Regulatory
    Emergin Feb 2006 - Jan 2008
    Us
  • Imaging Diagnostic Systems
    Director, Software Product Development
    Imaging Diagnostic Systems Oct 1996 - Oct 2006
    CTLM - Laser Mammography
  • Cap Gemini America
    Software Engineer Consultant
    Cap Gemini America 1989 - 1995
  • Coopers & Lybrand Consulting
    Management Consulting
    Coopers & Lybrand Consulting Jan 1984 - 1989

Gary Becker Skills

Quality System Iso 13485 Medical Devices Fda Capa Quality Assurance Quality Management Design Control Cross Functional Team Leadership Testing Iso Validation Process Improvement Fmea Six Sigma Gmp Healthcare Information Technology Software Documentation Software Quality Assurance Regulatory Affairs Iso 14971 V&v Continuous Improvement Biomedical Engineering Process Simulation 21 Cfr Part 11 Manufacturing Ce Marking Quality Auditing R&d Root Cause Analysis

Gary Becker Education Details

  • Stony Brook University
    Stony Brook University
    Computer Science
  • Usaf - Beale Air Force Base
    Usaf - Beale Air Force Base
    Inventory Management Specialist

Frequently Asked Questions about Gary Becker

What company does Gary Becker work for?

Gary Becker works for Aventusoft Llc

What is Gary Becker's role at the current company?

Gary Becker's current role is Director Quality Regulatory Affairs.

What is Gary Becker's email address?

Gary Becker's email address is gm****@****ast.net

What is Gary Becker's direct phone number?

Gary Becker's direct phone number is +156148*****

What schools did Gary Becker attend?

Gary Becker attended Stony Brook University, Usaf - Beale Air Force Base.

What skills is Gary Becker known for?

Gary Becker has skills like Quality System, Iso 13485, Medical Devices, Fda, Capa, Quality Assurance, Quality Management, Design Control, Cross Functional Team Leadership, Testing, Iso, Validation.

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