Mariyam Akter began her Medical Device Regulatory Affairs and Quality Assurance (MDRQ) program journey with a sense of dedication and fervor. Despite balancing the rigorous coursework and raising a newborn amidst the Covid pandemic, she recalls the experience at the sitem-insel School as overall positive. She attributes her success to the supportive administration and the networking opportunities with her experienced peers. «Through this network, I had the opportunity to gain insightful knowledge,» she highlights.
Impact on career and regulation understanding
The MDRQ program, in cooperation with the University of Bern, served as a launch pad for her career as a Regulatory Affairs Specialist at the renowned Ypsomed AG, with a focus on innovation projects, software, and digital products. The course provided her comprehensive knowledge of medical device regulations in numerous territories, including Europe and the US. «The Master (program) boosted my critical thinking ability, which was very useful for my project. And I can make a good contribution to the regulatory strategy,» Mariyam Akter acknowledges.
Acquired skills and real-world application
She highlights crucial skills she gained, like making a regulatory submission, communicating effectively with health authorities, and understanding how to engage in various stages of product development. «Regulatory Affairs actually is a vast topic. As a regulatory person, we are involved from product development to end of market, and even after post market maintenance activities,» she explains how the MDRQ program prepared her for real-world challenges.
Memorable opportunities and enduring impact
One of the standout opportunities Mariyam Akter recalls is the Industry Based Learning (IBL), where students apply the knowledge acquired during their studies in a company. «I had the opportunity to develop my master thesis in a renowned medtech company, that I admire. And I'm really happy to be part of it,» she shares this priceless experience.
Advice for future MDRQ students
Mariyam would recommend the MDRQ program to anyone looking to establish their career in the medtech industry. She emphasizes that the program offers the chance to work in multidisciplinary departments, from quality assurance and design to medical affairs and legal. «With the MDRQ program, you have the opportunity to move in different directions,» she concludes.
