Ankur Datta
About Ankur Datta
Ankur Datta is the Manager of Regulatory Affairs at Teleflex in Delhi, India, with extensive experience in regulatory and quality management roles across various companies in the medical and pharmaceutical sectors.
Current Role at Teleflex
Ankur Datta currently holds the position of Manager for Regulatory Affairs at Teleflex in Delhi, India. This role involves overseeing regulatory processes, ensuring compliance with local and international regulations, and maintaining effective communication with regulatory bodies. His extensive knowledge and experience in regulatory affairs are instrumental in enhancing the regulatory strategies at Teleflex.
Previous Experience at Avanos Medical
From 2019 to 2022, Ankur Datta worked at Avanos Medical as Manager for Regulatory Affairs & Quality in the South Asia region. Based in the New Delhi area, his responsibilities included ensuring regulatory compliance, implementing quality management practices, and liaising with regulatory authorities to secure marketing licenses for medical products.
Prior Roles at HCL Technologies and Abbott
Before his tenure at Avanos Medical, Ankur Datta was employed at HCL Technologies as a Senior Project Manager in Regulatory for 11 months from 2018 to 2019 in Bangalore. He also served as Manager for Regulatory Affairs & Quality at Abbott from 2013 to 2018 in the New Delhi area. In these roles, he was responsible for managing regulatory submissions, quality assurance, and developing regulatory strategies.
Educational Background
Ankur Datta obtained a Post Graduate Diploma in Pharmaceutical Regulatory Affairs from Jamia Hamdard between 2012 and 2013. He also holds an M.Sc. in Microbiology and Microbial Technology from the University of Kalyani, completed from 2005 to 2007, and a B.Sc. in Microbiology from the University of Calcutta, completed from 2002 to 2005. Additional certifications include ISO 13485 QMS Internal Quality Auditor from DNV, and ISO 9001:2008 QMS/EHMO Internal Auditor from the Bureau of Indian Standards (BIS).
Specialized Skills and Certifications
Ankur Datta has a comprehensive skill set that includes conducting gap assessments and remediations of IVD technical files for EU IVDR compliance, serving as a Management Representative for QMS, and liaising with the Central Drugs Standard Control Organization (CDSCO) for marketing licenses. He has developed Quality Management Systems and is certified in both ISO 9001:2008 and ISO 13485:2008 standards. His experience extends to conducting various phase studies, handling tender processes, and setting up warehouses and distributors.