Emergo Group Homepage Contact EMERGO

Krista Oakes - Senior Consultant, Regulatory Affairs

  • Printer-friendly version

Since 1989, Krista Oakes has been involved in quality assurance and regulatory affairs in the medical device industry. Krista has worked with large and small manufacturers representing a broad spectrum of medical device technologies. Prior positions include Director of Quality Assurance and Regulatory Affairs for Quest Medical, Vice President of Regulatory Affairs and Quality Assurance for Epic Medical, President of Epic Medical, and Vice President - Medical Device Division for Shotwell & Carr.

Krista is an active participant in the medical device industry with memberships in the Regulatory Affairs Professionals Society (RAPS), the American Society for Quality (ASQ), and the Association for the Advancement of Medical Instrumentation (AAMI); and currently serves as the industry co-chair for the Dallas District FDA/Medical Device Industry Coalition. Krista has been an industry speaker and author of articles on practical and efficient approaches to quality systems.

EXPERIENCE:

Vice President, Regulatory Affairs, Neuro Resource Group, Inc. (2004-2008)
  • Compliance and quality system operations
  • Domestic and international regulatory submissions
Vice President, Medical Device Division, Shotwell & Carr, Inc. (2002-2004)
  • Substantially revived firm's medical device business in the U.S.
  • Secured and led projects responsible for more than 50% of firm's billable hours.
  • Provided regulatory and quality consulting to large and small medical device firms.
  • Introduced and marketed "business-friendly" approach to compliance.
VP of QA & RA, then President, Epic Medical Equipment Services (1999-2002)
  • Responsible for all compliance and quality system operations.
  • Responsible for domestic and international regulatory submissions.
  • Established company quality system for QSR and ISO compliance; brought company to ISO 9001/EN46001 certified status in less than one year.
  • Brought company from recidivist warning letter to an NAI (no 483) status with FDA.
  • Substantially reduced product complaint rate from 9% to less than 1% of units sold.
  • Changed company culture to engage and motivate all employees in quality practices; secured support from all members of management.
  • Developed CE mark and other international regulatory strategies; obtained CE mark for class IIb medical devices.
Director, Quality Assurance and Regulatory Affairs, Quest Medical, Inc. (1995-1999)
  • Assumed responsibility for all compliance and quality system operations.
  • Improved operations while reducing staff.
  • Established new quality system after company split/reorganization, using a "quality at source" approach.
  • Upgraded quality system certification from ISO 9002 to ISO 9001.
  • Responsible for complaint handling, document control, and regulatory compliance.
  • Improved complaint handling/failure investigation process while reducing cycle time.
  • Obtained 510(k), CE mark, and Australian registration for implantable devices
    Regulatory Affairs Specialist.
  • Responsible for international and domestic regulatory submissions.
  • Conducted quality system audits.
  • Obtained CE mark for Class III devices.
Regulatory Affairs Administrator & QA Coordinator, Surgimedics, Inc. ( 1989-1995)
  • Responsible for complaint handling, document control, 510(k) regulatory submissions, nonconforming material control, and product release.
  • Designed automated complaint handling and document control software; identified and implemented a unique opportunity to market software to the medical device industry, creating revenues of $100,000 during the first year of implementation.
  • Wrote company quality manual.
  • Significantly streamlined operations while improving quality of output.
  • Unanimously voted "employee of the year" by executive management.
  • Improved complaint handling/failure investigation process while reducing cycle time.

AREAS OF EXPERTISE:

  • Anesthesiology
  • Autologous blood recovery
  • Biofeedback devices
  • Cardiovascular surgical & monitoring
  • Dental devices
  • Disposables and reusable devices
  • Electronic devices
  • General hospital and surgical devices
  • Imaging devices
  • Implantable devices
  • In-vitro diagnostic devices
  • IV delivery devices
  • Neurostimulation
  • Obstetrical monitoring
  • Organ transplant devices
  • Orthopedics
  • PACS systems
  • Pulse oximetry
  • Respiratory care
  • Software-driven devices
  • Sterile devices (EtO and Gamma)
  • Surgical lasers
  • TENS devices

EDUCATION:

  • Bachelor degree in Psychology, Brigham Young University

HOME BASE:

  • Texas, USA