Rita Ahmed
Accomplished Regulatory & Quality Leader | Regulatory Operations | Product Complaints and Surveillance | Business Intelligence and Analytics
- Role
- Sr Ra Manager Eudamed Rim Product Registration Mdr Vigilance at Edwards Lifesciences
- Location
- Orange, CA, US
- LinkedIn followers
- 500 followers
About Rita Ahmed
Results-driven Program Leader with 20+ years in life sciences, medical devices, and technology, specializing in Regulatory, Quality, Compliance, and Business Systems. Expert in strategic planning and process improvements to optimize global regulatory operations. Skilled in CAPA, post-market quality, complaint handling, and audits.Leadership Expertise • Strategic Planning • Program Governance • Stakeholder Management • Executive Communications• Risk ManagementRegulatory Expertise Med. Device• RIM - Regulatory Information Mgmt.• Regulatory Intelligence Management • Operations - Regulatory Business Process Distribution Control, and SystemQuality Expertise • QMS, CAPA, DMAIC Lean Sigma• Post Market Product Surveillance•Reporting, Trending/ Statistics• Process Validation and VerificationBusiness and Analytics• Reporting dashboard - quality & regulatory• Quality post market product performance complaints trending• Data analytics tools, and process• System Vendor selection process
Experience
Sr Ra Manager Eudamed Rim Product Registration Mdr Vigilance
Jan 2022 — Present · Irvine, CA, US
Spearheading a multi-phase global initiative of the product registration system to enhance operational efficiency.Leading EUDAMED MDR UDI compliance, data readiness, system upgrades and provide executive oversight of Clinical/Vigilance reporting to comply with MDR regulations.
Education
St. Cloud State University
MBA, Management Information Systems and Services
2036
Texas A&M University
Applied Statistics, MS Applied Statistics
2036
Southwest Minnesota State University
BS and BA, Computer Science and Business Finance
2036
Anoka-Ramsey Community College
AS, Biomedical Device & Regulation
2036
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