Rolando Stanghellini

WORK HISTORY

ABOUT ROLANDO STANGHELLINI

Executive with more than thirty-five years of experience in the medical device fields, in the area of Quality Assurance, Quality Systems and Product / Process compliance and Validation, Auditing, Process control, International Regulatory, etc. Third party QMS MDD and ISO 13485 for EU, as well as MDSAP Lead Auditor qualified by BSI (British Standard Institute NB 0086 - NB 2797). Design and development of QMS, as well as QMS gap analysis assessment, compliance methodologies and quality systems, development SOP documentation and provide training. International Quality System Design and Certification, MDD - MDR and ISO 13485 for EU, as well as MDSAP jurisdictions. Management and support on project related to CAPA and QMS remediation and deviation, assist and support in root cause investigations, complaint, risk management and change control. Regulatory compliance support in defining regulatory strategy from both an FDA and European standpoint. International Regulatory Registrations (EU MDD, USA FDA 510K and PMAs, Shonin, ANVISA, etc.). Management with success of several audits with FDA, MHRA, EU Notify Body, Mexican and Czech Republic Department of Health; Clinical and animal studies organization and management; Contacts with international universities for biomechanical and clinical qualification of devices. Specialties: Business Development, Quality and Regulatory Affairs Multi-Sites Strategy and Management, Leadership and Team Building, Products Development Process, Business Process Re-Engineering Management, Project Management, Merges & Acquisitions.