Helping clients is my main goal. Bringing regulatory knowledge on medical devices and combination products is my expertise. Clients value my input as being of high quality and they appreciate the open communication and collaborative approach in projects. My background is a PhD in Medical Sciences and a master in Medical Biology. At Starodub, I am a senior medical device expert.
Since 2005 I gained a broad knowledge of regulatory affairs in a global setting, both on medical devices and pharmaceuticals. I have been the RA global project lead for technical documentation and submission strategies, health authority communications (pre-submission/scientific-advise meetings; Notified Bodies, Agencies, EMA, FDA, National) and product-lifecycle management. I am trained on GCP, GMP, QM (ISO 13485/9001), risk management and auditing. I am a member of RAPS. 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. My specialty is RA project management, product classification, technical documentation coordination and writing, scientific advice, medical device/combination products knowledge exchange (Presentations and Training), submissions and labeling.
At Starodub, I appreciate next to the professionalism combined with flexibility and variety, the client-oriented teamwork and the continuous effort to improve our business.