James R. Moore (Jim)519 South Trunnel Avenue

Meridian, Idaho 83642208.631.0003 fax 208.855.9298

Email: jimmoore50@hotmail.com

Summary

A Certified Regulatory Affairs Professional (RAC) with experience in small, medium and large FDA regulated industries with emphasis on Class I, II and III medical device firms. Interprets U.S. and foreign laws, regulations and policies and creates quality, compliance and submissions programs that include technical requirements, industry standards, vendor variations, international quality principles and company marketing priorities. Prepared and received approval for 510(k), IDE and PMA product submissions in cardiovascular, dental, ophthalmic, general hospital, and other device categories.

Served as primary regulatory and quality contact for employers, gained significant management and operational experience in sales, marketing, product/business development, service and company-wide quality systems by incorporating and championing enterprise resource management programs (ERP) as tools to integrate and promote excellence and quality throughout each organization.

Established vendor qualification programs for US and Mexico based suppliers including working directly with production, engineering, QA and management personnel to meet and exceed purchasing specifications and requirements.

Additionally, served as a Certified Assistive Technology Professional (ATP) conducting more than 500 in-person interviews and prepared written evaluations required by Medicare/Medicaid for complex rehabilitative power wheelchairs and other durable medical equipment.

Accomplishments

Obtained ISO-9001 and EN-46000 certification in 7 months from MEDCERT, a notified body headquartered in Hamburg, Germany, by utilizing a combination of executive, staff and external resources to revise the Quality System to meet both QSR and ISO requirements. As a result, CE mark was added to Accutron products ahead of schedule.

Created a QSR/GMP documentation program that is fully integrated with accounting and business systems for Accutron, Inc. Five inspections by the FDA over 10 years resulted in no inspection deficiencies (no FD-483 observations).

Directed the Regulatory Affairs activities for Bausch & Lomb’s International Division, which generated more than $75 million in revenues in 25 countries, with more than 150 products and 8 manufacturing facilities. Reorganized administrative and service operations resulting in cost savings of $300,000 (reduced 25%) in the first year. Revised labels and labeling for more than 100 professional and consumer products distributed in the US, Canada, Mexico, UK, Europe, Middle East, Japan, Korea and Australia.

Served as liaison between academic researchers (John Hopkins, Washington University), government funding agencies (NASA, NIH), and subcontractors (Novo Denmark, Parker-Hannifin, Pacesetter Systems) participating in development of implantable infusion pumps for diabetic and pain control drugs. This multi-disciplinary program resulted in a commercially marketed external pump from Minimed, Inc.

Created Medicare Quality System accreditation program including writing, editing, and issuing procedures and training personnel on those Quality System and operating procedures for a Medicare complex rehabilitative power wheelchair distributor. Personally provided information to Quality System auditor for HQAA (accrediting organization) including responding to audit discrepancies with a corrective action plan sufficient to meet HQAA’s accrediting committee resulting in accreditation in September 2009.

Created for rehabilitative power wheelchair manufacturer/distributor -- Quality Manual (tier one), standard operating procedures (tier two), applications instructions (tier three), history records documents (tier four) including document change order system (DCO), QSR CAPA and preventative action programs using internal personal and external consultant resources, internal audit programs for OEM.

Managed the successful U.S. launch of knitted vascular graft developed by researchers at Coats & Clark in Scotland. Directed FDA approval activities, clinical study programs, personnel recruiting and sales training. Created sales training manual and sales territory agreements.

James Moore Resume Page 2 of 2

Employment History

Intertek Pharmaceutical Services: Whitehouse, New Jersey, 2014 to presentQuality, Supplier and Compliance Auditor

Oriel Stat A Matrix; Edison, New Jersey; 2014 -- presentSenior Management Consultant (Medical Device Quality Systems and Regulatory Affairs)

Alliance Seating and Mobility, division of The Scooter Store; territory office Meridian, IdahoCertified Assistive Technology Professional (ATP); 2010 -- 2013

Redman Power Chair, Tucson, ArizonaATP Evaluations, Operations and Regulatory Affairs Director; 1998 -- 2010

Accutron, Inc., Phoenix, ArizonaOperations, Quality and Regulatory Affairs Manager; 1994 – 1998

Laser Medical Technology, Inc., San Clemente, CaliforniaDirector, Regulatory and Clinical Affairs; 1992 -- 1994

Accutron, Inc., Phoenix, ArizonaRegulatory and Quality Manager; 1989 -- 1992

Baxter-Pharmaseal, Valencia, CaliforniaManager, Regulatory Compliance and Quality Assurance; 1986 -- 1988

Bausch & Lomb, Inc., Rochester, New YorkDirector, International Regulatory Affairs 1985 -- 1986

Pacesetter Systems, Inc., Sylmar, CaliforniaDirector, Regulatory Affairs; 1980 -- 1984

Intermedics, Inc., Freeport, TexasManager, Regulatory Affairs; 1978 -- 1984

U.S. Food and Drug Administration (FDA), Phoenix Arizona and Houston, TexasConsumer Safety Officer (Investigator); 1974 -- 1978

Education Business and Public Administration graduate courses

Arizona State University, Tempe, Arizona, B.S. Biology,

Northwest Missouri State University, Maryville, Missouri Certified Nuclear Reactor Operator,

U.S. Navy Nuclear Power School, Mare Island, California and Idaho Falls, Idaho

Certifications and Affiliations Regulatory Affairs Professional Society, Certified Regulatory Affairs Professional, RAC RESNA (Rehabilitation Engineering and Assistive Technology Society of North America)

Certified Assistive Technology Professional (ATP) American Society for Quality Control North American Society of Pacing and Electrophysiology

Other Patents Awarded – U.S. Patent Number 5,673,451 for invention “Instructional Toothbrush” Published author – The Six Trillion Dollar Man -- fiction Service-connected disabled veteran Board member, Idaho College and Career Readiness Academy, Meridian, Idaho