Sonya Stenfelt
Senior Consultant
PhD
sonya.stenfelt@regsmart.se +46 (0)767-610 292
With a PhD in polymer chemistry and extensive experience in biomaterials and stem cells, Sonya excels in regenerative medicine. Her background includes overseeing manufacturing changes and scaling production, showcasing her ability to navigate complex environments effectively.
More about Sonya
Sonya has a PhD in polymer chemistry and dedicated most of her earlier academic carrier to research on biomaterials and stem cells for regenerative medicine and disease modelling.
She has a 6-year experience of working under ISO 13485 and QSR. Her responsibilities included new registrations, change control, product life cycle management, regulatory compliance and audit readiness on multiple markets such as US, Canada, Australia, Russia, China and EU, including transition to MDR. Her CMC profile included responsibilities such as handling changes in raw materials, utilities, manufacturing processes/equipment, changes to cleanrooms and utilities and up-scaling.
Prior to joining RegSmart, Sonya had the role of a Senior Process Design engineer developing automated industrial scale bulk manufacturing processes for new injectables and handling CAPA and deviations for existing products.