Freelance consultant specializing in Regulatory Affairs & Clinical Project Management within medical device trials. Strong research professional with a background in Biomedical Sciences and a Master in Clinical Research obtained at the University of Antwerp, Belgium.
Active for 8 years in the medical device industry. Skilled in overseeing and coordinating day-to-day management of clinical projects from design to closure with focus on multi-service clinical research projects. Previously involved in several projects (pre- and post-market) with a focus on delivering quality, performing regulatory submissions in accordance with the relevant legislations, meeting sponsor project timelines and ensuring overall compliance to ICH-GCP, ISO 14155 and any local regulations.