Prasad R.

Team Lead @Celegence

Tamil Nadu, IN

Lead Regulatory Compliance team for In-vitro diagnostic medical devices and medical devices.• Gap assessment, Remediation plan preparation for technical documents of Medical devices, IVD & Standard compliance.• Remediation of Technical Documents, GSPRs in compliance to EU IVDR 2017/746 and EU MDR 2017/745.• Authoring PMS documentations PEP, PER, CPR, APR, SVR, SSP, PMSP, PMSR, PSUR.• Review of DHF & DMR documents.• Regulatory strategy for EU, FDA, CDSCO, Middle East, South American countries & Others.• SaMD regulatory submissions involving Laboratory Information Management System.• Handling of Clinical Trial documents including Regulatory Intelligence.• Perform review of Technical, clinical and PMS documents and provide feedback for the authors.• Risk Management activities in compliance with ISO 14971 & ISO/TR 24971.• Product registrations of medical device major’s and India.• Manage customer communications and project management.• Conduct training programs for team members for medical devices requirements.• Support Authorized Representative (AR) and Person Responsible for Regulatory Compliance (PRRC) activities for EU.• Drafting of SOP’s & Manuals.• Actively engage with internal stakeholders and cross-functional client business teams such as Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs.

E.S.Matric.Hr.Sec.School

Higher Secondary Education, School

SRM Arts & Science College

Bachelor of Science (B.Sc.), Biotechnology

University of Madras

Master of Science (M.Sc.,)/ Master Of Technology (M.Tech.,), Nanoscience & Nanotehnology

Anglia Ruskin University

PG Certificate, Biotechnology