Laura Leal
Sr. Director QA/RALife Sciences I Medical Device QA & RA Global Compliance
- Role
- Sr Director of Quality and Regulatory at Infobionic.Ai
- Location
- San Diego, CA, US
- LinkedIn followers
- 500 followers
About Laura Leal
Quality and regulatory affairs professional with over 26 years of dynamic experience in the medical device industry. Excellent understanding of US and Global regulatory requirements. Expertise in QMS implementation for (21 CFR 820, ISO, 210, and 211, CMDCAS, MDSAP, MDD>MDR, IVDR, TGA, JPAL, ANVISA, MDSAP, RUO, IUO, etc), business expansions and market growth, mergers and acquisitions, global QMS compliance, site inspection preparation and readiness, remediation, effective PMP, PMO program implementation, Quality Improvement Plan generation, ISO certification, and QMS improvement and maintenance.Skilled at providing strategic analysis and leadership in development and implementation of quality and regulatory strategies to gain product approval and/or certification maintenance. Proven track record applying quality tools and methodology to enhance and create cost effective innovative solutions. Excellent interfacing, collaborative, and relationship building skills, able to lead, train, and implement successful projects.
Experience
Sr Director of Quality and Regulatory
May 2025 — Present
Education
University of San Francisco
Bachelor of Science (B.S.), Organizational Behavior Studies
2006
Southern Polytechnic State University
Candidate for MSQA, Industrial Engineering
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