Janki Parekh

Janki Parekh is a Regulatory Affairs Specialist with extensive experience in the medical device industry, currently employed at BioSerenity since September 2022, providing regulatory support for device development and overseeing submissions to regulatory bodies such as the EU notified body, FDA, and Health Canada. Previous roles include serving as a Regulatory Affairs Consultant at AIXIAL, where Janki managed medical device registrations and compliance with EU MDR 2017/745, and as a Regulatory Affairs Specialist at Coloplast, where responsibilities included international registrations, product modifications, and regulatory documentation. Educational background includes a Post Graduate Certificate in Regulatory Affairs from Humber College and an Honours Bachelor of Science in Biology from York University.