Tajanka Mladenovska is a member of the regulatory team at Hydrix. She recently sat down with us to share a little bit about herself.
Tell us about your role ?
I’m a member of Hydrix’s regulatory team, assisting clients with insights and guidance for market access, and helping guide and develop global regulatory strategies. I also undertake regulatory remediation work for clients taking existing products into new markets or battling with compliance with the ever-changing regulatory environment. Finally, I coordinate the compilation of submissions and direct interaction with the regulatory bodies.
I’m also becoming more involved in the medical device development process. I have always been passionate about medical devices and their application and really enjoy working on all aspects of the medical device lifecycle: design, safety, regulatory approval, market entry and reimbursement, and through to obsolescence. So, what really excites me in my role is that the regulatory team plays an integral role in medical device development projects, and it is this combination that enhances both technical solution and regulatory conformance. Being able to draw upon the depth and breadth of Hydrix’s product development team allows me to better work with clients in providing truly comprehensive regulatory solutions.
You previously worked for the Therapeutic Goods Administration (TGA)
Yes, I was predominantly performing conformity assessments and technical evaluations of class III medical devices, which is particularly valuable in my new role given we have many clients in the implantable medical device space. I also have interests and experience in the areas of biomaterials, biocompatibility and bioprinting, and application of ISO 10993, which is very relevant to many Hydrix clients.
You have a substantial academic track record.
Thank you! I started out with a Bachelor of Science degree in Biomedical Science and followed that with a Masters in Human Clinical Embryology. Then, I undertook a Masters of Health Policy as my interest developed from research and clinical practice to medical devices and regulatory. My main project in my Masters of Health Policy was in the regulatory area, exploring a proposal for the TGA to use an expedited conformity assessment process, applicable to high risk medical devices already certified by European Notified Bodies.
Currently, I’m undertaking a PhD focusing on the regulation and research translation of 3D bioprinting for orthopaedic surgery. The project aims to develop direct translation and commercialization models for 3D bioprinting and to aid its integration into everyday surgical use.
In her spare time, Tajanka is actively involved in the local (Melbourne, Australia) MedTech start-up community, and participates in various mentoring and teaching programs. She will shortly be speaking at a 5-day Biomedical Engineering Innovation Workshop “From Ideation to Innovation in Regenerative Medicine” for PhD students at the University of Melbourne.
