Poornima Sureshkumar
Angestellt, Regulatory Affairs Coordinator, Eurocor GmbH
Köln, Deutschland
Über mich
Responsible for the timely preparation of international marketing authorization submissions for the product-line. certified ISO 13485 auditor (from The British Standards Institute), Experienced Knowledge Management Specialist with a demonstrated history of working in the research industry, assisting the Coordinator on 3 EU funded projects bridging scientists and project management specialists from 15 different academic and industrial institutions. I am professionally skilled in Microsoft Office tools, Quality Management System, Controlled Documentation, and project management.
Werdegang
Berufserfahrung von Poornima Sureshkumar
Bis heute 2 Jahre und 5 Monate, seit Feb. 2022
Regulatory Affairs Coordinator
Eurocor GmbH
Submission preparation for International Marketing Authorisations ICH-GCP/National and International Fundamentals of Pharmaceutical Regulations and Medical Devices EU MDR, IVDR Documentation: Clinical Study- Pharmaceuticals and Medical devices Regulatory affairs: Compliance to AMG, MDR and IVDR
4 Jahre und 6 Monate, Juli 2011 - Dez. 2015
Mitarbeiterin Knowledge Management and Documentation
Universität zu KölnManaged submissions to European Framework Program (FP7), Documented technical reports for three FP7 projects in stem cell research (DETECTIVE, ESNATS, STEMCAM), Coordinated communications between project partners from Academic research with Industry Prepared regular project reports Performed Quality control on project documentations and coordinated with project management team in assessment of project delays, GLP, SOPs, QMS
2006 - 2010
PROCESS EXECUTIVE
Tata Consultancy Services Ltd
Served as the Subject Matter Expert (Product Reference) for Nielsen Services- A Market Research project (Client located in the USA) Performed Classification, coding, and validation using Citrix based server Handled client communications Performed quality management tasks as the team’s internal quality monitor. Tasks included error identification, clarification/correction, and providing internal training Performed Data management tasks
Sprachen
Deutsch
Fließend
Englisch
Muttersprache