Wes White BS, RAC

Experience

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  Medtronic

  Jun 1986 - Jan 1995

  Preclinical GLP testing of cardiac pulse generators in canines. Performed bioengineering monitoring of anesthetized canines for cardiac lead testing including capture thresholds, pulse widths, and impedance data collection. Analyzed and documented clinical site study data of right ventricular dp/dt pressure changes for detection of congestive heart failure and changes in arterial pressure for detection of ventricular fibrillation.

  • Study Coordinator

    May 1989 - Jan 1995

  • Research Technician

    Jun 1986 - May 1989
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  Medtronic Physiological Research Laboratory

  Jan 1995 - Dec 2008

  Senior Scientist

  Many years of experience with research and implantable medical devices in managing preclinical studies in animal models.Complemented my preclinical expertise in regulatory affairs by obtaining a Regulatory Affairs Certification (RAC) designation through the Regulatory Affairs Professionals Society (RAPS). As a Senior Scientist for 15 yrs. in a study director role, was the single point of control and responsible for compliance to Good Laboratory Practices regulations for preclinical studies submitted to the FDA for regulatory review.Real time experience with the surgical procedures used to implant cardiac devices and data interpretation of the devices that were tested and submitted to the FDA for approval. Collaborated with scientists and engineers in the development of study designs and protocols for investigational cardiac devices and prototype neuromodulation devices. Researched and developed appropriate animal models including congestive heart failure.The study director serves as the single point of control, is responsible for the compliance to the Federal Register Good Laboratory Practices regulations, and leads a multidisciplinary team in the development, conduct, and completion of these studies. Show less

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  American Preclinical Services

  Dec 2009 - May 2012

  Quality Assurance Specialist II

  Acted as subject matter expert in Good Laboratory Practices and FDA Regulatory Affairs.Experience auditing cath lab interventional procedures using various animal models.Reviewed GLP study protocols for compliance and completeness.Performed critical phase inspections within laboratory environmentAudited scientific GLP interim and final reports for completeness and accuracyParticipated in Standard Operating Procedure (SOP) writing and developmentProvided training and expertise to staff on FDA regulatory compliance topics and facility SOP'sPerformed data audits and report reviews to assure accuracy and compliance with Good Laboratory Practice (GLP) regulations, study protocols and laboratory Standard Operating Procedures (SOPs).Reviewed protocols and amendments for GLP compliance, accuracy and compliance with US and international testing guidelines. Assisted with client and government inspections, subcontractor inspections, updating the master schedule, data form reviews, critical phase inspections, facility inspections and equipment validation programs. Performed as the archivist for the research testing facility.March 2010- Attended "Regulatory Affairs 101"​ sponsored by LifeScience Alley.November 2010- Attended "General Considerations for Animal Studies for Cardiovascular Devices"​ sponsored by LifeScience AlleyMay 2011- Attended two day Internal Auditor Training for ISO 17025 in Chicago.June 2011- Attended "Obtaining and Marketing Your 510(k) with Today's FDA, a 510(k) Workshop" sponsored by LifeScience Alley.April 2012- Attended 28th Society of Quality Assurance Annual Meeting in Miami including two day GLP Quality College workshop. Show less

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  Medtronic Neuromodulation

  Sept 2012 - Dec 2012

  Product Performance Specialist

  Reviewed in-scope infusion drug pump device complaint files for sufficiency of information to determine if there is a product non-conformance or therapy related issue reportable to the FDA using the Global Complaint Handling (GCH) database system for coding of product and therapy related drug pump issues.Attended week long "Targeted Drug Delivery Therapy Training for Neuromodulation Sales Training" course for Synchromed II drug delivery pump.Working knowledge of the Product Performance Specialist (PPS), Medical Device Reporting (MDR), and Adverse Drug Experience (ADR) work instruction documents.Understanding of Medtronic Quality System documents. Show less

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  Medtronic

  Mar 2013 - Apr 2015

  •Strong understanding of CRDM products and their clinical application, with in-depth knowledge of product category, including an understanding of failure modes and clinical implications•Perform compliant investigations and assess for product performance issues. This includes assessing complaints with respect to returned product analysis results, clinical data, and manufacturing data for the Returned Products Analysis (RPA) lab.•Initiate the root cause investigation and corrective action processes. •Draft reports and other technical documents. •Ensure the correct application of the quality system.•Assist Technical Services and Physician Communications departments in assuring accurate and meaningful information is communicated to the customer.•Assist MDR and Regulatory Affairs as necessary to aid in the response to inquiries or to prepare for regulatory reports. Show less

  • MDR Specialist

    Nov 2013 - Apr 2015

  • Reliability Engineer

    Mar 2013 - Nov 2013
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  Boston Scientific

  Oct 2015 - Feb 2016

  Product Performance Analyst- Retired

  Analyzes customer complaints to determine which are regulatory reportable and coordinates activities with internal, field, and end use customers. Responsible for adherence to Good Manufacturing Practices and proper complaint handling per the Code of Federal Register and other governmental regulations. Communicates event investigation results via regulatory reports and written communications. Read and summarize technical papers, professional journals, and social media articles that have productperformance and quality issues for submission in the complaint handling system. Show less