John Sawyer Email and Phone Number
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Experienced professional/executive with expertise specializing in cybersecurity, medical devices, invitro-diagnostics, software, electronics, electro-mechanical, and aerospace industries. Strong multi-functional cybersecurity, quality assurance, regulatory affairs, risk management, and clinical experience. Extensive managerial, mentoring and training experience. Demonstrated ability to expand beyond the scope of assigned responsibilities to gain proficiency in other areas. Critical thinker and innovative problem solver, able to see the business and technical sides of a problem. Ability to provide alternate solutions to resolve critical issues.Primary responsibilities have been focused on establishing and improving quality systems and regulatory strategies for both domestic and international modalities. These responsibilities have ranged from compliance to ISO-9001, ISO-13485, European Medical Device Regulation (MDR), European Invitro-Diagnostic Regulation (IVDR), CMDCAS, and FDA’s Quality System Regulation and development of Institutional Review Board (IRB) procedures.An integral member of various executive management teams focused on new product development, commercialization, and product clearance/approvals for various modalities. Ensured robust compliance programs for Quality Management, Regulatory Affairs, and Cybersecurity aligned with organizational growth and product portfolio expansion.Proven leadership, negotiation and problem resolution abilities with regulatory agencies as a result of audits, inspections, and/or recall activity. Exceptional communication skills, both oral and written. Published author and conference speaker.Specialties: •U.S. FDA Quality System Regulation•European Medical Device Regulation (MDR))•ISO-27001 Information security, cybersecurity, and privacy protection requirements•Regulatory Issues: 510(k)’s, Recalls, MDR’s & IRB’s•ISO-9001-2015 – Quality Management System Requirements•ISO 13485-2016 – Medical Devices - Quality Management System Requirements•IEC-62304-2015– Medical Device Software - Software Life Cycle Processes•ISO-14971-2019 Risk Management for Medical Devices•European Guidelines on Medical Devices Vigilance System•AS 9100-2016 Aerospace Quality System Requirements
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Owner - PresidentRealistic Quality Solutions Llc Jun 2010 - PresentLake Mary, Florida, UsConsultant to the medical device industry on establishing and remediating quality systems to comply with ISO-9001, ISO-13485, and FDA's Quality System Regulation. Provide training on all aspects of quality systems and regulatory affairs. Provide assistance in obtaining medical device clearances and approvals through FDA's 510(k) process, MDD CE Mark and electrical/mechanical safety per IEC 601 and collateral standards. Assist in Establishment Registration and Device Listing. Audit quality systems & regulatory practices based on FDA regulations and guidances as well as international standards. Perform - Assist with software, design, and process validation activity. Establish quality & regulatory strategies for start-ups and existing businesses as well as international firms who want to market in the U.S. Handle FDA Inspections and recall strategies and initiatives. Assist in corrective action activity based on results of regulatory audits and recommendations.(response to FDA 483 Observations, Warning Letters, ISO Nonconformances) Perform due diligence for acquistions and establishing supplier partnerships. Work at both domestic and international locations (i.e. Germany, China, Singapore, France, Netherlands etc.). Lead Instructor for various quality system related courses with AAMI. Lead Quality Management Systems Auditor performing contract work for German Registrar/Notified Body.
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Owner - PresidentRealistic Quality Solutions Llc Jun 2010 - PresentLake Mary, Florida, Us
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Vp Quality Assurance & Regulatory AffairsCardiac Science Apr 2009 - Jun 2010Deerfield, Wisconsin, UsI am a regulatory and quality professional with over 23 years of experience working in the medical device, aerospace and electronic industries. I am an ASQ Certified Quality Auditor as well as a registered Lead Quality Management System Assessor. My work has focused on domestic and international quality and regulatory issues from implementation and evaluation of quality systems to product compliance with appropriate safety standards for electrical and mechanical safety.I have been responsible for:1. Obtaining product approvals for the medical device industry to all U.S. and international standards for electrical and mechanical safety. This includes 510(k) clearances, national marks for Germany, the “CE Mark” for the EEU member states (European Medical Device Directives, Annex II) and the “CB” scheme for medical devices for other international markets.2. Assisting organizations in registering as a medical device manufacturer and determine classification of products (i.e. Class I, II, and III) and approval process to be sought after (i.e. 510(k), PMA clearances from FDA).3. Establishing quality systems to meet and effectively evaluate the requirements of the U.S. FDA Quality System Regulation, ISO-13485, and ISO-9000 for various organizations. 4. Evaluating, Maintaining and improving existing quality systems for various organizations and where necessary, ensured that adequate corrective action was obtained.5. Working with ISO Registrars/Notified bodies on evaluating quality systems per the requirements of ISO-9000, ISO-13485, and the European Medical Device Directive.I am a member of RAPS, AAMI and AAMI’s GMP Education Subcommittee. I have had several articles published as well as having made several presentations to various industry groups on quality assurance and regulatory affairs topics. -
Vice-President Quality Assurance & Regulatory AffairsWelch Allyn May 2003 - Mar 2009Skaneateles Falls, New York, UsAs the Vice-President, Quality Assurance & Regulatory Affairs, I was responsible for compliance of all facilities(eight) to FDA’s Quality System Regulation, ISO-9001 and ISO-13485. Responsible for all 510(k) submissions from all sites – average submissions for past year has been ten submissions. These were filed as Traditional or Abbreviated Submissions. Responsible for obtaining all product approvals and product registrations both domestically and internationally. Responsible for all complaint and MDR Reporting for all facilities. Responsible for all corrective actions at all sites to FDA 483 Observations. Responsible for establishing the corporate quality assurance program, goals and objectives to meet and effectively evaluate the requirements of the U.S. FDA Quality System Regulation, ISO-13485 and ISO-9001. Obtained product approvals and maintained product compliance and labeling authority to U.S. FDA and international standards for electrical and mechanical safety. This includes preparation and submission of 510(k) & PMA clearances, preparation and submission of Canadian Medical Device Regulation clearances, national marks for Germany, the “CE Mark” for the EEU member states (European Medical Device Directives, Annex II) and the “CB” scheme for medical devices for other international markets to include China, Japan, and Brazil. Assisted design and product development groups to ensure all product approval activities including validation activities occur as planned per current design controls methods and requirements. Where required, coordinated and documented clinical activity/customer preference testing for non-significant risk studies through the IRB process. Prepared all associated documents for the IRB and worked with study monitors and principal investigators to complete studies as outlined in the study protocol.
John Sawyer Skills
John Sawyer Education Details
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University Of UtahCybersecurity Bootcamp -
Cornell UniversityCybersecurity
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Tampa Business CollegeBusiness Administration
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Tampa Business CollegeGeneral
Frequently Asked Questions about John Sawyer
What company does John Sawyer work for?
John Sawyer works for Realistic Quality Solutions Llc
What is John Sawyer's role at the current company?
John Sawyer's current role is Owner - President at Realistic Quality Solutions LLC.
What is John Sawyer's email address?
John Sawyer's email address is j.****@****nce.com
What is John Sawyer's direct phone number?
John Sawyer's direct phone number is +180173*****
What schools did John Sawyer attend?
John Sawyer attended University Of Utah, Cornell University, Tampa Business College, Tampa Business College.
What skills is John Sawyer known for?
John Sawyer has skills like Fda, Iso 13485, Medical Devices, Quality System, Capa, Cross Functional Team Leadership, Design Control, Regulatory Affairs, Gmp, Six Sigma, Product Development, Quality Assurance.
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