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• Over 6 years of professional experience in international & domestic regulatory affairs.
• Successfully assisted two FDA audit and completed with no observation.
• Experienced working with pharmaceutical industry including pre-market submissions, software as a medical device (SaMD), strategic decisions and post market surveillance.
• Lead 30+ programs and manage critical timelines
• Sponsor of Career exchange program at Northeastern University
• Adviser at Regulatory Affairs Program at Long Island University
• Knowledge of ICH GCP, GMP, US CFR, Canadian, EU regulations, guidance and laws covering their interpretation.
• Comprehension of market activities for Class I, Class II, CLASS III devices include assisting in 510(k)/PMA submissions, regulatory strategies, registration, listing, document change control, Medical Device Reporting, Field Corrective Action Teams, Recalls, Regulatory Change Action Process.
• Understanding of Preparation and maintenance of Essential Requirements Checklist and Technical File, and support Notified Body review and approval of technical files.
• Working Knowledge of Technical Dossier/STED for product submissions, renewal and maintaining International registrations, including working with teams of distributors and consultants.
Specialties:
• Ability to assimilate complex technical concepts and summarize for use with regulatory agencies.
• Capacity for working in fast paced teams with the ability to build excellent working relationships.
• Strengths - communication, negotiation, research and analytical skills.
• Proficient in ISIToolbox, Predict, SharePoint, Agile Documentum, XML , Microsoft Word and Excel.