Svetlana Oestergaard

I have a MSc as physician biophysist from Moscow Medical University (1995), MSc in biochemistry from the University of Copenhagen (2002) and PhD from the Faculty of Pharmaceutical Science at the University of Copenhagen (2011).

I have 20 years of experience in the medical industry and consultancy. During my career I hold diverse positions: as a Scientist in the R&D department in the in-vitro diagnostics company, Regulatory Affairs Specialist at medical device company, QA audit in pharmaceutical company.

In the period of 2018-2022, I have worked as Technical Assessor and Auditor at the Notified Body (Presafe, DNV), where I got a lot of experience in assessing compliance of technical documentation for medical devices related to Medical Device Directive and (EU) Medical Device Regulation and providing recommendation for CE certification.

Today I work as a Regulatory Affairs Specialist at Phillips-Medisize, a medical device company with a strong expertise in design and development of drug delivery devices.