Gabriela Maldonado-Codina

WORK HISTORY

EDUCATION

ABOUT GABRIELA MALDONADO-CODINA

Seasoned program management leader with Ph.D. in molecular biology and 15+ years’ experience in medical device product development and product life cycle management (including In Vitro Diagnostic (IVD) devices). Technical background and product strategy experience allows an in-depth understanding of projects. • Lead projects: deliver milestones on time and on budget, guiding teams to think critically and solve problems effectively. • Devise holistic plans with aggressive but realistic timelines (including design transfer to manufacturing considerations). • Rapidly create and grow project leadership expertise through mentoring of existing in-house talent. Experience with Design Controls requirements for medical device and IVDs. • Draft and implement ISO 13485/MDSAP compliant top-level Design Controls procedures delivering a compliant design and development process. • Partner with quality team, or outside firm, to implement full Design Controls QMS and prepare for ISO certification. • Partner with regulatory team to drive timely regulatory submissions. Practiced portfolio manager with experience developing numerous diverse products including commodity products, complex medical devices and combination products. • Support for strategic planning. • Create and implement a right-sized process balancing organizational needs to drive executive-level project prioritization and oversight. • Pressure test business plans/roadmaps for implementation, including identifying gaps in expertise, competencies and required resources.