Gillian Marland

Senior RA Manager

With a PhD in biochemistry and post-doctoral experience in immunological research, I started working in regulatory affairs in 2005 at a leading medical device company. Since then, I have been involved in regulatory compliance of medical devices throughout the life cycle, from design and development to the post-market phase.

My specialty is post-market surveillance, encompassing vigilance, safety recalls and post-market planning and reporting. This includes risk management according to ISO 14971, as well as setting up post-market surveillance and vigilance systems in accordance with the EU MDR, UK MDR 2002 and ISO 13485. I have extensive experience in liaising with regulatory authorities on vigilance and safety recalls. Accuracy and attention to detail are qualities I utilize to ensure that written communication is unambiguously formulated and factually correct. I am a native English speaker and am fluent in Dutch.

I am proud to work for STARoDub and to be part of a team of experts providing clients with high-quality regulatory services.