Donielle Baudin
Sr Director Regulatory and Quality @Levita Magnetics
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WORK HISTORY
Sr Director Regulatory and Quality @Levita Magnetics
Mt. View, CA, US
As the Sr. Director of Regulatory and Quality at Levita Magnetics I lead our efforts to ensure product safety, compliance, and market readiness across global markets. My role involves:• Strategic Leadership: Crafting and executing comprehensive regulatory and quality strategies to align with international standards and drive market access.• Regulatory Affairs: Managing the submission processes for regulatory approvals and maintaining strong relationships with regulatory agencies.• Quality Management: Directing the development and enhancement of our Quality Management System (QMS) to ensure our products meet the highest safety and effectiveness standards.• Cross-functional Collaboration: Partnering with R&D, manufacturing, and marketing teams to integrate regulatory and quality considerations into every phase of product development.• Risk Management: Identifying and mitigating risks related to regulatory compliance and product quality and overseeing the implementation of corrective and preventive actions.• Team Leadership: Leading and mentoring a talented team of regulatory and quality professionals, fostering a culture of excellence and continuous improvement.• Compliance Monitoring: Ensuring ongoing adherence to industry standards, regulations, and company policies through regular audits and reviews.
EDUCATION
University of Phoenix
Bachelor's Degree, Business Administration, Management and Operations
SKILLS
ABOUT DONIELLE BAUDIN
A strategic quality leader bringing over 25 years of experience with a diverse background in startup, mid-size and Fortune 25 environments. Successfully leading new product development in both Class II and Class medical devices from concept through commercialization. Demonstrates success in developing and implementing adaptable quality management systems that drive business growth while upholding product quality standards. Proficient in applying problem-solving skills with a risk-based approach to drive actionable plans, effectively achieving company strategic and financial objectives.
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