Gabriela Maldonado-Codina
Program Management Consultant experienced in accelerating and de-risking regulated medical device, In Vitro Diagnostic, and biotechnology product development and approvals.
- Role
- Owner at Impact Consulting, Llc
- Location
- Longmont, CO, US
- LinkedIn followers
- 500 followers
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.
Experience
Owner
Jan 2023 — Present · Boulder, CO, US
Education
University of Sussex
Bachelor of Science (BSc) Hons, Biology, General
1985 — 1988
University of Dundee
Doctor of Philosophy (Ph.D.), Molecular and Cellular Biology
1988 — 1993
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