Sandra Dejean

PharmD, Regulatory affairs, Medical devices / In vitro diagnostics

Sandra Dejean is Doctor of Pharmacy with a masterís degree in regulatory affairs and quality management for medical devices and ancillary medicinal substance. Her experience includes more than 8 years spent in the medical devices and in vitro diagnostics industry. She has notably worked on worldwide registrations that led to one European approval (CE marking process) for an absorbable device made from material from animal origin, US licenses (510(k) clearances) for two in vitro diagnostics and one implantable device as well as two high risk medical devices licensed by Health Canada. Sandra has also worked on regulatory approval process for a medical device that includes an ancillary human blood derivative in Europe (prior European Medicines Agency review and final EC certification by a Notified Body) and in the US (Investigational Device Exemption (IDE) and Premarket Approval (PMA) inspection preparation). She has also implemented European regulatory framework changes (reclassification of medical devices falling within higher risk class, change of Notified Body, clinical evaluation requirements) to successfully maintain health products on the market.

Sandra has recently defended the PharmD thesis untitled "Implementation of a regulatory framework for veterinary medical devices: impact analysis" that has been rewarded by the French Academy of Pharmacy. She is now providing consultancy services that cover regulatory and quality requirements for medical devices and in vitro diagnostics firms in human and veterinary sectors.