Amina Baljic 

Consultant/ Regulatory Services Advisor

Amina is a certified and seasoned regulatory professional with over 10 years of accomplished experience in medical devices and healthcare regulatory fields. She holds Regulatory Affairs Certification (RAC) for both Canada and the USA from the Regulatory Affairs Professionals Society (RAPS). She has a Master of Science in Pharmacovigilance from the University of Hertfordshire and a post-graduate diploma in Regulatory Affairs from Humber College. 

Her professional experiences have allowed her to build her expertise in all major areas of health care regulations such as Medical Devices, Pharmaceuticals, Biologics etc. Having worked in regulatory and drug safety in brand companies like 3M Health Care, Novo Nordisk, and Glaxo SmithKline, and in quality and supply chain as a service provider, she is able to advise on the regulatory impact of all types of changes and product introductions to drive approval and compliance. She has led and participated in a multitude of inspections such as Health Canada’s PV, GMP and Medical Device inspections, ISO certifications as well as FDA and MHRA inspections.

Amina is passionate about her work, and in her spare time enjoys traveling. 

MD&D Expertise Areas: Medical devices, Canadian MD&D market, Health Canada regulations, Regulatory affairs, Quality, Regulatory Affairs Certification (RAC), Regulatory Affairs Professionals Society (RAPS), Health Canada Pharmacovigilance, GMP and Medical Device inspections, ISO certifications, US FDA and MHRA inspections