Skilled leader with expertise in quality assessment, complaint management, both pre- and post-market product approval, associated regulatory reporting compliance, e.g., pharmacovigilance, field corrective action (FCA), and managing both internal and external quality assessment of operations. Designed, developed, reviewed and implemented quality, regulatory and operational systems. Developed and defined monitored account program to further timely product performance results. Participation in Complaint Review Board to ensure effective problem resolution and appropriate action taken and documented. Ongoing quality system review including document review, revision and initiation of regulatory documentation as needed. Reviewed, approved and closed medical device, drug and pharmaceutical complaints including associated regulatory documentation. Ensured quality issues were investigated, resolved and closed in an effective and timely manner. Developed and harmonized global pre- and post-market quality systems, e.g., Clinical QA, Adverse Event Reporting, Product Surveillance, Quality Assessment, Field Corrective Action and Regulatory Documentation/Filings. Primary Contact for FDA and global regulatory agencies, e.g., TUV .

Highlights:

• quality systems
• regulatory reporting
• quality assessment
• field corrective action
• complaint management
• quality assurance