Welcome Magdalena!
We are very excited to share the news about our latest addition to the team, PhD Magdalena Karlsson, who joins us as Senior QARA Specialist.
Magdalena is an experienced senior scientist with extensive experience from the industry and authorities. Her background is comprehensive and include Biomarkers, Statistical Modelling, Bioinformatics, In Vitro Diagnostics, Biotechnology, Clinical Research, and Medical Device Regulation. She joins Yallow as senior QARA Specialist and discipline lead of IVDR. She will also be responsible for our SW compliance team that we are looking to grow and expand in 2023.
With the new IVD regulations that introduces substantial changes in the regulatory framework for in vitro diagnostic medical devices we expect an increased demand of advising and how to navigate the transition from IVD to IVDR so the timing of bringing onboard an expert like Magdalena could not better.
Magdalena joins Yallow after a position as Quality and Regulatory Manager at Oxy Solutions and before that senior advisor at the Norwegian Medicines Agency. She brings solid and valuable experience that from day one will be appreciated from our customers.
I am very happy to have Magdalena on board. With her we continue our growth and strategy of building a world class team of QARA Specialist. We also add new offerings with her experience in IVD and Software where we see a huge gap of available competence and specialists in the market so I am sure our customers will appreciate Magdalena’s competence in this field
I am so much looking forward to become part of this very exciting journey – guiding both existing and new manufacturers to smart and efficient solutions and advancing the healthcare services.