Quality Assurance Medical Device
Resume:
Robert G. Clift
Cartersville, Georgia 30121
abnrdq@r.postjobfree.com
Objective
A challenging senior management position in Quality Assurance or Regulatory Affairs with a rapidly
growing start up or small medical device manufacturing facility.
Employment
Automated Treatment Pathways Atlanta, Ga
30144
Partner Oct. 2008
- Present
GlucoTec Inc Greenville, SC 29615
V.P..Quality Assurance/Regulatory Affairs Sept. 2006 to August
2008
Regulatory Consulting Services Atlanta, Ga 30120
Senior Regulatory Consultant June 1999 to July
2005
Healthdyne Technologies Inc Marietta, Ga. 30067
Director, Global Quality Assurance, /Regulatory Affairs January 1980 to March 1999
Area’s of Expertise
Cardio – Respiratory Monitoring and Diagnosis (510k) Class II
Medication Delivery/Dosing Systems – Infusion Pumps, MDI’s, Oxygen; ECT. (510k) Class II
Automated Treatment Pathways (510k) Class II
Sleep Diagnostic and Therapy Systems (510k) Class II
Uterine Activity Monitor (PMA) Class III
Home Needle Destruction System (PMA) Class III
Sudden Infant Death Syndrome Monitoring and Diagnostic Systems (510k) Class II
International Device Regulations – MDD, IEC, ISO, EN, 13485, ECT
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FDA Quality System Implementation
Professional Investigator - Adverse Events – Medical Devices
Submission of PMA’s and 510 (k)’s
Acquisition Due Diligence
Supplier Quality
Software QA
Clinical Trials
Accomplishments and Responsibilities
Official Correspondent FDA
Responsible for Establishment Registration and Listing
Investigated all serious injuries, deaths, and malfunctions likely to cause the afore stated.
Official Management Representative
Working relationship with staff at FDAs ODE, Compliance, Enforcement, Legal, Regulatory, and Office
of Science and Technology
Responsible for registering six medical device manufacturing facilities, in accordance with Annex II, of
the Medical Device Directive with Notified Body L.C.I.E., Paris, France.
Created and implemented FDA’s Quality System Requirements and ISO 13485 at four class II and III
startup medical device manufacturing facilities.
Designed and implemented Clinical Trials with several major institutions with regard to Diabetes, Sleep,
SIDS, Sleep Apnea, Cardio Respiratory, and Drug Delivery Systems.
Authored and co-authored several 510(k) Pre market Notifications and two PMAs.
Led over twenty routine and for cause in depth FDA investigations
Responsible for training executive, mid level, direct supervisors, and production employees with regards
to FDA's Quality System Requirements, ISO 13485, the Medical Device Directive, and the CE marking
process.
Developed initial and subsequent modifications to the Quality Assurance and Regulatory Affairs
program, to delineate areas of responsibility, personnel requirements, and operational procedures within
programs, according to company goals and objectives
Directed over 80 employees, at five U.S and two International manufacturing facilities, scheduled work
hours, resolved conflicts, and determined salaries
Established fiscal budgets for Quality Assurance and Regulatory Affairs departments
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Conducted Management Review meetings with the Board of Directors and Executive management to
establish, delineate, and review the effectiveness of all aspects of the business
Organized and conducted comprehensive Design Review Meetings.
Developed Supplier Quality Assurance Programs
Reviewed technical publications, articles, abstracts, to ensure all Regulatory requirements were met and
competition, to stay abreast of the latest technical developments in the cardio respiratory, sleep, drug
delivery, and diabetes health care arena
Member executive due diligence acquisition team – QA/RA
Reported directly to the Chairman of the Board
Education
Broome Community College Binghamton, New York
1975-1976
State University of New York Binghamton, New York
1976-1979
Lead Assessor - Victoria Group 1995
Kennesaw College Kennesaw, Georgia
Advanced Statistics 1997-1998
Affiliations: RAPS, ASQ
FDA Southeastern District - Invited speaker and Panel member:
Seminar and Training session for FDA and Industry
QSR and Design Controls 1997 Atlanta, Georgia
References
Mr. Steve Birch PhD. - V.P. Marketing, Cardinal Health - San Diego, California. Previous colleague
1990 – Present
Mr. Tim Cowart J.D. - V.P. Regulatory Affairs - Healthdyne and Healthdyne Technologies. I reported
directly to Mr. Cowart. Lawrenceville, Ga. 1984 - Present
Mr. Bay Ingram - Former C.E.O. and Board member GlucoTec. I reported directly to Mr. Ingram. Slidell,
La 2006 – Present. Mr. Ingram currently is owner of Southern Surgical
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Coach Dave Roberts - Special Advisor Government Affairs – GlucoTec, Greenville, S.C. 2006 - Present
Additional Personal and Professional references available upon request.
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