Summary of qualifications Global Quality System and Regulatory Compliance Experience in Regulated Environments (Medical Device/Pharmaceutical/Food/In-Vitro Diagnostics) including implementation of design controls * Global Regulatory and Quality Compliance (creating processes for Field Actions/point of contact for all recalls with the FDA/806 and monthly reporting) * Regulatory partnering with FDA and International Agencies : *Creating Global Regulatory Strategies *Create and review various submissions including amendments and supplements for 510K, Technical Files, Design Dossier, STED and IDE/PMA including Combination Products * Experienced in all Project Management activities (design through product approvals/launch) * Experienced in Hiring/Training including setting and sticking to budget * Experienced in Quality/Regulatory/Compliance Systems development, implementation and refinement across multiple business units and sites * Experienced in creating and presenting Site Quality/Regulatory metrics to Vice President Staff Members * Experienced in creating, reviewing and approving protocols and reports for: *Software *DocumentChanges/Methods/Sterilzation/Validations/Qualifications/Nonconformances/COA's/Audits/ Out of Specifications/Trends/Stability/Engineering documents * Experienced in method development and implementation (R&D to Production across multiple sites) * Experienced as a Compliance (FDA/ISO/HACCP) Trainer * Experience in setting up Testing Labs for cGMP/GLP compliance * Experienced as a Certified Quality Lead Auditor (Internal and Vendor Audits) * Application of Six Sigma to problem solving (DMAIC/DFSS process)

Highlights:

• Documentation
• Infrastructure
• Management
• Program Management
• Budget Preparation
• Budgeting
• Development Activities
• P&L
• Product Development
• Project Management