Maëlys has a global vision and broad-ranging experience within the healthcare sector, where she has worked for more than 5 years. She also has a strong foundation in research, having worked in fundamental, applied, translational and clinical research areas.

Before joining NAMSA in June 2021, Maëlys worked as Project Manager, Technical Leader and Quality Supplier within the sterile sampling industry, where she gained multi-faceted experiences in product development and industrialization. She gained validation expertise implementing a Beckman Coulter Particle counter in batch release testing. Additionally, Maëlys supported a Class III medical device Post Market Surveillance (PMS) department in the complaint-handling unit for an FDA audit. Maëlys also worked at Servier’s Research Institute as a research intern in the translational and clinical oncology department. She experienced the role of a Clinical Research Associate intern at CHRU Hopital de la Cavale Blanche (Brest, France) in the Clinical Research Nephrology team in a self-sponsored investigational study.

Maëlys has a Bachelor degree in Science and a Master degree in Cellular and Molecular Biology from University of Rennes 1, France. She currently is a Project Manager for IVD.

CORE COMPETENCIES

• Project management and technical leadership for product development and industrialization
• Regulatory project management supporting clients for IVDR readiness and regulatory assessments
• Clinical project management supporting sites in both EMEA and US
• Experienced in molecular and cellular biology, molecular diagnostics (MDx), oncology, nephrology and virology disciplines

RECENT PROJECTS

• Usability study for Substance Abuse Testing for Near-Patient Testing (NPT)
• IVDR readiness for diagnostic software, Multiplex Respiratory Panel and instruments