Electrical Engineering, Regulatory Affairs, Pharmaceutical Products, FDA Expert Consultant Resume
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Resume of TYY
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  • Electrical Engineering
  • Regulatory Affairs
  • Quality Assurance
  • Medical Device
  • Pharmaceutical Products
  • FDA

B.S. Electrical Engineering Technology, Metropolitan State College, Denver, CO (Graduated with Honors)
Master of Business Administration in Operations Management, Regis University, Denver, CO (Graduated with Honors)

Twenty-five years working in the Medical Industry in the areas of Regulatory Affairs, Quality Assurance, Clinical Studies, R&D, Test, Manufacturing and Technical Service.
 
The last fourteen years have been spent serving numerous clients worldwide as a Regulatory Affairs Consultant, providing compliance, submissions and training services to the Medical Device and IVD Industries. 
 
Expert knowledge of US FDA, Health Canada and the European Medical Devices Directive regulations.
 
Regulatory Experience:
  • Product Approval/Clearance Submissions (e.g., 510(k)s, PMAs)
  • Combination Device/Drug Submissions
  • Common Technical Document for Pharmaceutical Products
  • Medical Device (IDE) Clinical Trial Protocol Design, Management, Analysis and Report writing
  • Quality System Manual and Quality System Procedure Origination
  • Design Control, CAPA, Complaint Handling, Process Control and Records Development
  • FDA 483, Warning Letter and Notified Body Assessment Responses
  • FDA QSR and ISO 13485 Audits
  • Quality System Training 
  • Auditing Medical Device and Pharmaceutical Clinical Trials
  • Import/Export Issues (e.g., 801(e), Certificates of Exportability, etc.)
  • Technical Files and CE Marking
  • Product Reports for Subchapter J – Radiological Health
  • Recalls, Safety Alerts and Physician Advisories

Consultant, Kevin Kennedy Associates, Inc., Indianapolis, IN
Providing expertise in Regulatory Affairs, FDA, medical device and pharmaceutical products to a wide variety of clients.
 
Principal Consultant, a consulting firm, Littleton, CO
Work with clients in the medical device and pharmaceutical industries to develop quality assurance, manufacturing, and regulatory strategies for compliance with the FDA and other worldwide regulatory bodies and gain product approval / clearance by:
  • Writing and submitting 510(k) Premarket Notifications, and Premarket Applications (PMA’s), including for Combination (Device/Drug) Products.
  • Creating Common Technical Documents.
  • Designing and managing clinical studies on human subjects.
  • Conducting assessments of client studies, procedures, and programs to determine compliance to cGMP’s, GCP’s and GLP’s.
  • Producing Quality Systems Manuals, Policies and Procedures to comply with worldwide regulations and standards.
  • Developing and implementing corrective action plans to address deficiencies in companies’ quality systems.
  • Authoring responses to FDA-483’s and Warning Letters and instituting strategies for bringing companies back into compliance.
  • Compiling technical files to support the CE marking of products.
  • Achieving ISO-13485 Registration and CE marking.
  • Training company employees in all aspects of regulatory affairs and quality systems. 
Director, Regulatory Affairs & Compliance, Fischer Imaging Corp., Denver, CO
Managed corporate regulatory affairs and quality systems to comply with worldwide regulations and standards.
  • Acted as Quality Management Representative at Executive level.
  • Chaired Corrective Action Board.
  • Managed Design Control and Technical File Teams.
  • Handled clinical trials and product submissions for government approval/clearance.
  • Managed FDA inspection and ISO-9001 assessments, along with the responses to deficiencies.
  • Represented company for the National Electrical Manufacturers Association (NEMA).  
Senior Regulatory Affairs and Quality Systems Development Specialist, GAMBRO Healthcare, Lakewood, CO
Prepared regulatory strategies, 510(k), IDE submissions and monitored clinical trials.
  • Developed internal regulatory and quality procedures.
  • Coordinated FDA inspections and ISO-9001 assessments.
  • Managed FDA-483 and warning letter responses, along with all corrective actions leading to the clearing of warning letters.
  • Coordinated recalls and other field actions.
  • Managed quality systems audit program.
  • Provided corporate quality systems training.
  • Member of the Management Review Team and Technical Advisory Group. 
Technical Manager, Cochlear Corporation, Englewood, CO
  • Managed Technical, Customer Service and Documentation departments.
  • Handled PMA submissions and supplements.
  • Coordinated FDA inspections and FDA-483 responses.
  • Developed company quality system procedures.
  • Assisted with the development of new products and accessories. 
Production Test Manager/Electrical Design Engineer, Bard Electro Medical Systems, Englewood, CO
  • Managed Production Test department.
  • Developed test procedures and fixtures.
  • Designed new products and supported the design of current products.

1985                            The National Dean's List
1986                            Tau Alpha Pi National Honor Society
1986                            Golden Key National Honor Society
1987                            National Collegiate Engineering Award
1987                            Academic All-American Collegiate Award
1984, 85, 86, 88        Vice-President's Honor Roll
1986, 87, 88               Colorado Scholar's Award
1999                            Regulatory Affairs Certified

  • Regulatory Affairs Professionals Society (Certified).
  • American Society for Quality – Biomedical Division

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