Bhumika Suthar

Regulatory Affairs Specialist @Cardinal Health

Mississauga, ON, CA

Review and approval of new product introductions to determine compliance with licensing requirements of applicable Regulations (medical devices, drugs, NHPs, cosmetics).Classify medical devices, as per Health Canada’s Medical Devices Regulations, risk-based classification systemWork collaboratively with Marketing and Data management, as well as various suppliers in setting up new products in MDG SAP systemAddressing and responding to regulatory queries from customers and suppliersManaging new supplier set up and supplier maintenance activitiesManaging customer licensing process using JDE system and work closely with customer care team if needs to get required information from customers to upgrade them in our system to be able to purchase various drugs from usReviewing, troubleshooting and releasing orders that went on hold and upgrading customer license status when applicableAssist with other regulatory tasks as required such as help with MDEL and DEL renewal