Jack Austin

Jack Austin

Bio

Since joining the Secure BioMed Evaluations team in the summer of 2014, Jack has been responsible for assisting clients in regulatory, quality, and project management matters. Jack has experience assisting clients with all aspects of the Design History File creation, including creation of Design Control and Risk Management documentation and reviewing and managing Design Verification and Validation testing. Jack has assisted with ISO/Internal audits and creating and modifying Quality Procedures. Jack has participated in the generation of numerous successful regulatory submissions, including 510(k)s, 513(g)s and Pre-submission applications.

Prior to working at SBME, Jack graduated from University of Georgia with a Bachelor of Science in Biology. After graduation, Jack attended the Georgia Institute of Technology to obtain a Master’s Degree in Biomedical Innovation and Development through the Wallace H. Coulter department of Biomedical Engineering. This program focused not only on medical device research and development, but the entire regulatory, quality and clinical process. While in this program, Jack gained experience as the Clinical/Quality/Regulatory Manager of his master’s project in completing a variety of technical tasks and associated documentation for medical device development. Jack has leveraged the experience gained through this program for continued successes for SBME partners and clients.

Quality System Management
  • Full Quality System Management including: Document Control, Record Control, Quality Planning and Completion of Quality Objectives, Quality Management Representation, Training, Risk Management, Design Control, Labeling Control and Review, Internal Audits, Supplier Management and Auditing, Corrective and Preventive Action, Complaint Investigation and Adverse Event Reporting, Field Action (Recalls), NCR Investigation and Resolution, and Product and Process Controls
  • Drive Quality System performance and continual improvement through the establishment and ongoing evaluation of quality metrics
  • Maintain licenses and perform related periodic reporting
Regulatory Submissions
  • FDA clearance of medical devices
  • CE marking of medical devices
  • Successfully assist numerous companies during audits performed by FDA, EU Notified Bodies
  • Assist and maintain Clinical Evaluation Reports for obtaining and renewing CE certification
  • Review marketing materials for regulatory compliance and author compliant and effective marketing materials
Due Diligence and Project Management
  • Perform Quality and Regulatory aspects of due diligence for product and company acquisitions and report findings via a risk/benefit approach
  • Manage development projects to ensure regulatory compliance and adherence to desired timelines
  • Manage project teams to ensure the highest quality of work and most efficient development
Experience in the Following Therapy Areas
  • Orthopedic and Spinal Implants and Instrumentation, Neurological Surgical Mesh, Wound Coverings, Electronic Medical Devices, and Cosmetic Devices
August 2014 – Present
Secure BioMed Evaluations

Biomedical Innovation and Regulatory Manager
Technical Quality Lead

  • Assist Quality Management during all ISO/Internal audits, inspections and audit and inspection follow-up.
  • Responsible for product release, design history files, and device master records, etc.
  • Provide leadership in the qualification of new product transfers from Design Control and manufacturing processes including sterilization validation, and product stability programs.
  • Perform technical activities to ensure all design control requirements are met. Translate new product clinical needs into design inputs and outputs.
  • Represent SBME to product development partners and OEM suppliers regarding quality standards and requirements. Provide technical leadership for complex projects that involve multiple technologies (electronics, computer systems/software, etc.).
  • Responsible for the identification of issues and initiation of actions to prevent the occurrence of any nonconformity relating to products, processes, and the quality system as applicable to the responsibilities outlined within this job description.
  • Contribute to and develop regulatory strategies for product approval by both domestic and foreign agencies.
  • Prepare timely and compliant submissions to domestic and international regulatory agencies (including 510(k), IDE, CE dossiers, supplements, responses, product registrations, etc.).
  • Identify, collect, review and evaluate information critical to submission packages.
August 2013 – August 2014
Master of Science – Biomedical Innovation and Development

Georgia Institute of Technology. Atlanta, GA

August 2008 – May 2011
Bachelor of Science—Biology

The University of Georgia

Jack Austin

7828 Hickory Flat Highway, Suite 120, Woodstock, GA 30188

(770) 837-2681

JAustin@SecureBME.com

800-361-0945

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