Since 2003 I have been working for small, mid-sized and multinational pharmaceutical and medical device companies in Quality and Regulatory Affairs. I gained experience in various fields of medical devices and combination products. This includes product lifecycle management of implants, electro medical devices, and software and combination products.
I have experience as RA and QA manager and as a representative in ISO Standard committees. I am trained on the usual medical device standards QMS (ISO 13485) risk management (ISO 14971), software (IEC 62304), usability (ISO 62344), Biological safety (ISO 10993) and on Management Review, Clinical evaluation and auditing. Additionally, I am experienced in the review, drafting and application of templates and/or procedures for quality management (ISO 13485); Risk Management (ISO 14971), management reviews and clinical evaluations.
At Starodub, I would like to provide clients with the best and efficient science-based support. Furthermore, I would like to contribute to the further development of the Starodub medical device business with the help of my professional colleagues.