Dilsat Pinar Pergjetani

Dilsat Pinar Pergjetani has worked in various roles and companies throughout their career. Dilsat is currently serving as the Chief Quality & Regulatory Affairs Officer at Human Care Group since February 2022. Prior to this, they worked at Philips, starting from July 2011 to February 2022. During their time at Philips, they held various positions including Correction and Removal Manager Europe, Post Market Surveillance & Regulatory Affairs Manager for the Nordic region, Regulatory Affairs Manager for the Nordics, and Quality & Regulatory Affairs Specialist for the Middle East, Turkey, and South East Europe.

Before joining Philips, Dilsat worked at Alvimedica as a Regulatory Affairs Specialist from June 2010 to July 2011. Dilsat'sresponsibilities included preparing CE design dossiers, submitting them to notified companies, and managing the registration process for various regions.

Prior to Alvimedica, they worked at Atamis Health Group as a Regulatory Affairs Responsible from September 2009 to June 2010. In this role, they presented regulation files, translated DMFs, and closely followed legislation and regulations while collecting and submitting data to regulatory agencies.

Overall, Dilsat Pinar Pergjetani has a diverse background in quality and regulatory affairs, with extensive experience in the healthcare industry.

Dilsat Pinar Pergjetani completed a Bachelor's degree in Microbiology, General from Istanbul University from 2004 to 2008. Additionally, they obtained various certifications including Auditing to EU MDR from Philips in February 2019, Corrective and Preventive Action (CAPA) Training from US FDA Danışmanlık ve Eğitim/US FDA Consulting and Training in February 2013, The US FDA Quality System Regulations (21 CFR 820) from US FDA Danışmanlık ve Eğitim/US FDA Consulting and Training in February 2013, Medical Device Legislation and TITUBB (National Health Database) Training from Duzey Group Training in February 2012, Auditing ISO 13485 & 9001 Quality Systems with focus on marketing and sales processes from MIKROCENTRUM in January 2012, Medical Device and In-Vitro Medical Device Directives Training from TSE - Turkish Standards Institution in December 2011, and Regulatory Compliance, Post Market Surveillance and The Council Directive MDD 93/42 EEC Training from Kalitest in September 2011.