Maria Ida Iacono, PhD

Chief RAQA And Clinical Affairs - Global at Wandercraft

Maria Ida Iacono, PhD has extensive work experience in regulatory affairs and scientific review in the medical device industry.

Maria Ida currently holds the position of Director of Regulatory and Quality Affairs - Global at Wandercraft, a role they have held since January 2023. Maria Ida is responsible for overseeing regulatory and quality compliance on a global scale.

Prior to this, Maria worked at Wandercraft as the Director of Regulatory Affairs USA from September 2019 to February 2023. In this role, they developed and implemented regulatory strategies to ensure compliance with US regulations while achieving business objectives. Maria Ida authored pre-submissions and led discussions with the FDA review team.

From 2018 to 2019, Maria worked as the Director of Regulatory Affairs at BIOMODEX. In this position, they developed regulatory strategies for educational and future medical devices. Maria also had discussions with the FDA to determine product claims and disclaimers.

Maria's career began at the FDA in 2012, where they served as a Lead Scientific Reviewer in the Office of Device Evaluation. Maria Ida completed numerous premarket scientific reviews and served as a subject matter expert in MRI RF safety and computational modeling for medical devices.

Before joining the FDA, Maria held the position of Scientist - Biomedical Engineer from 2012 to 2018, where they were involved in research projects and served as a principal investigator and mentor.

Maria has also held academic positions, including a Postdoctoral Fellow at Harvard Medical School's Martinos Center for Biomedical Imaging from 2011 to 2012, and a Visiting PhD Student at the Harvard-MIT HST program from 2010 to 2011.

Maria Ida earned their PhD from Politecnico di Milano in 2011, where their research focused on MR image processing algorithms and data visualization. Prior to their PhD, Maria worked as a Research Assistant and Clinical Engineer at Fondazione I.R.C.C.S. Policlinico San Matteo Pavia.

Overall, Maria Ida Iacono, PhD brings a wealth of experience in regulatory affairs, scientific review, and research to their current role as Director of Regulatory and Quality Affairs - Global at Wandercraft.

Maria Ida Iacono, PhD has an extensive education history in the field of biomedical engineering. Maria Ida earned their Bachelor's degree from Liceo Classico Umberto I in Ragusa, Italy, where they received a diploma. Following their undergraduate studies, Maria went on to pursue a Master's degree in Biomedical Engineering at Politecnico di Milano. Maria Ida then furthered their education by completing a Doctor of Philosophy (PhD) in Biomedical Engineering at the same institution.

Maria's pursuit of knowledge in their field did not end with their PhD. Maria Ida also spent time as a Visiting PhD student at the prestigious Massachusetts Institute of Technology (MIT), where they had the opportunity to expand their expertise.

Additionally, Maria has obtained a certification in Introduction to the Principles and Practice of Clinical Research (IPPCR) from The National Institutes of Health, which they achieved in July 2022. This certification further demonstrates their commitment to staying current in their field and expanding their knowledge and skills.

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Timeline

  • Chief RAQA And Clinical Affairs - Global

    September 1, 2023 - present

  • Director of Regulatory and Quality Affairs - Global

    January 1, 2023

  • Director of Regulatory Affairs USA

    September, 2019

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