EMEA Regulatory Affairs Leader
W.L. Gore & Associates
I joined W.L. Gore & Associates in November 2018 as EMEA Regulatory Affairs leader, working actively on the transition to the MDR of our product portfolio and providing strategic guidance on EU requirements to our US-based structure.
Prior to this, I was with BSI Notified Body for 5.5 years. First, as a product reviewer, technical expert, project manager and QMS assessor. This position gave me some valuable experience on the technical, regulatory and auditing functions of the Notified Body. I then moved in the Notified Body Regulatory Lead for BSI 0086 in 2015. In 2017 and 2018, I have been actively involved in the preparation work for MDR to allow BSI to reach the key milestones in BSI designation under the MDR and IVDR.
I’m a qualified QP and pharmacist with a background in drug formulation with over twelve years of pharmaceutical industry experience with top pharmaceutical companies where I have worked developing and producing investigational drugs and clinical research.
Tuesday, October 27, 2020
09:45 – 10:45 CET