Asha Jacob, PhD, PCQI

Senior Manager Regulatory Affairs & Compliance at Philips

Speaker

I am a Regulatory Affairs and Compliance professional, and have a background spanning 11 years in the MedTech and Pharma industries, complemented by 12 years of experience in Research & Development for in-vitro devices and pharmaceuticals. My expertise encompasses various domains, including Technical Documentations, Regulatory Affairs, Clinical Affairs, Medical Writing, and Quality Assurance. Currently, I am Senior Manager and Head of Regulatory Affairs and Compliance Team, Philips Medical Systems, the Netherlands. I am also EU Authorised Representative (AR) Officer and Person Responsible for Regulatory Compliance -2 at the EU AR Office in Philips. In these roles I have designed, implemented, and managed a Philips-wide Assessment and Improvement Program for its Technical and Clinical Documentations in compliance to EU MDR (2017/745).