Jose A. Espino
Vice President, Quality and Regulatory Affairs @Young Innovations
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WORK HISTORY
Vice President, Quality and Regulatory Affairs @Young Innovations
Chicago, IL, US
Executive responsibility for Quality and Regulatory Operations for the company. Responsible for providing strategy and direction to all business units to ensure that Quality and Regulatory Affairs systems are established and maintained in accordance to domestic and international requirements.Responsibility for the QRA Function required to develop, manufacture and market products for the dental industry, including Drugs, Controlled Substances, Medical Devices, and Biologics. • Results and compliance oriented leadership and management experience with large organizations and private equity companies.• Expertise supporting M&A activities, including due diligence, integration, and divestiture. • Extensive hands-on expertise with structural, operational and strategic regulatory and systems remediation.• Leadership and operational expertise with remediation of companies, closing warning letters, 483’s, and quality systems audits.• Directly responsible for the effective oversight and management of teams that support Design Quality Assurance, Quality Management Systems, Supplier Quality Assurance and Post Market Surveillance.• Ability to identify and implement optimal QRA structures to improve quality, compliance and add value to the organization.• Extensive experience with regulatory compliance for management and distribution of Drugs, including Controlled Substances, and Tissue.• Expertise managing domestic and international Regulatory Affairs, including submissions, registrations, licenses, technical documentation, and surveillance. Extensive applied knowledge of Europe\'s MDR, Health Canada, FDA, and ROW regulatory needs.• Business partnership developing processes and programs to improve the bottom line while ensuring compliance and customer satisfaction. • Expertise managing and implementing programs for self-manufacturing, contract manufacturing, private labeling and distribution.
EDUCATION
Roosevelt University
MBA, Business Management
The George Washington University
Master of Science in Health Sciences (M.S.) , Clinical and Translational Research
ABOUT JOSE A. ESPINO
Dedicated and dynamic Senior Leader possessing an 20+ year track record of superior performance within the Medical Device & Pharmaceutical arena. Strategic and hands-on expertise in Corporate Compliance, Quality Assurance, Regulatory Affairs, Product Development, Manufacturing, Sourcing, Process Improvement, Personnel Development, and Integration of Acquisitions to support key initiatives across multiple businesses lines/product families within a progressive organization.Specialties: • Certified Six Sigma Black Belt - ASQ• Certified Quality Manager and Organizational Excellence - ASQ• Certified Quality Auditor - ASQ• Certified Process Analyst - ASQ• Certified Mechanical Drafter - WRHC• Certified Information Systems Analyst - WRHC
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