Robert Seiple

VP Quality Assurance and Regulatory Affairs


Robert Seiple has over 35 years of industry experience in medical devices, pharmaceuticals, radiopharmaceuticals, and food additives. Robert’s areas of expertise include: regulatory compliance, project management (new product development and compliance upgrades), creation of risk management documentation, marketing authorization submissions and Technical File preparation.

As President and Principal Consultant, Robert performs multiple functions for QPM clients including audits, training, responses to regulatory compliance actions (483 and Warning Letter responses), 510(k) and CE submissions, and Technical File preparation and review.

Experience

  • President and Principal Consultant, QPM Consulting – 2002 to present
  • Senior Consultant, Emergo – 2007 to present
  • Director, Compliance and Regulatory Affairs, MedTrials, Inc. – 2004 to 2007
  • Quality Assurance Manager, NeoRx Pharmaceuticals – 2003 to 2004
  • Senior Quality Assurance Manager, Zila BioTech – 1997 to 2002
  • Senior Research Scientist, Steris Laboratories – 1992 to 1997
  • Lab Supervisor, Compliance Manager, Total Quality Group Leader, The NutraSweet Company – 1984 to 1991

Areas Of Expertise

Including, but not limited to:

  • Anesthesia/respiratory
  • Cardiovascular
  • Combination devices
  • Cosmetic/plastic surgery
  • Dental equipment
  • Implants
  • In vitro diagnostics
  • Neurological
  • Orthopedic
  • Wound healing
  • Pharmaceuticals: radiological, topical, sterile injectables, oncology
  • Food supplements and additives Disciplines
  • Audits to: FDA QSR (21 CFR Part 820), ISO 9001:2015, ISO 13485:2016, CGMP (21CFR 210/211), GCP (21CFR 312/812, ICH E-6), MDD/MDR and MDSAP
  • Regulatory and Auditor training to the above standards
  • Due diligence audits - drug and device merger/acquisition candidates
  • Clinical trials - USA (IND, IDE, and pre-IDE)
  • Risk management per ISO 14971:2007 and ISO 14971:2012

Education

  • Master of Project Management
    Keller Graduate School of Business, 2003
  • Master of Science, Human Nutrition
    Ohio State University, Columbus, Ohio, 1981
  • Bachelor of Science, Microbiology
    Ohio State University, Columbus, Ohio, 1975

Project Apendix

(Overview – not comprehensive)
  • Regulatory lead for a 510(k) submission for a neonatal ventilator. Project included compiling hundreds of test documents, compiling and submitting the 510(k) to FDA, and working with FDA and the client to address questions from the agency.
  • Regulatory lead for a 510(k) submission for knee replacement device. Reviewed and compiled device description documentation for multiple predicate devices, reviewed extensive test documentation, compiled and submitted the 510(k) to FDA, and working with the FDA and the client to address FDA concerns and questions.
  • Regulatory lead for light-based acne therapy and aesthetics device. Reviewed and compiled device and clinical data, reviewed test data, compiled and submitted the 510(k) to FDA. Device subsequently cleared.
  • Regulatory lead for 510(k) clearance and CE approval for circulatory assist device primarily for patients with diabetic circulatory insufficiency. Reviewed test data, compiled and submitted information for both 510(k) clearance and CE Mark approval.
  • Over 20 successful quality management system implementation projects upgrading existing systems or creating new systems.
  • Performed an average of 10-12 quality management systems audits per year against multiple regulatory criteria (e.g., US, EU, Canada, and Japan).
  • Successful implementation of Unique Device Identification systems for multiple US device companies, including orthopedic implant products, life-sustaining Class II devices, blood bank equipment, and in vitro diagnostic products.

Other

Accreditations, memberships, publications, etc.
  • Regulatory Affairs Certification (RAC), US; received 2005
  • Regulatory Affairs Professional Society (RAPS) member
  • American Society for Quality (ASQ)
  • Toastmasters International (DTM)
Note: LaserACE® is not yet FDA approved or available in the United States. It is currently in clinical trials only in select areas outside of the United States.

Ace Vision Group, Inc.
39655 Eureka Dr, Newark, CA 94560
Telephone: 234-738-4074
234-738-4074

Ace Vision See Life NaturallyTM, LaserACE® and VisioLite® are registered trademarks of Ace Vision Group, Inc. All rights reserved. 2008-2020.