Description
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 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
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