Karthik Srinivas

About Karthik Srinivas

Hello professionals! Thanks for reaching my profile. This is Karthik S a Biomedical…

Experience

1. Senior Regulatory Affairs Executive

   Meril

   Nov 2023 — Present · Chennai, IN

   Prepare and update technical documentations as per DCGI, EU MDR and 510 (k) for surgical robot system regulatory requirements as required. Prepare and update risk management and usability evaluation as compliance with ISO 14971 and IEC 62366-1 Prepare and/or review labeling, IFU, surgical techniques and promotional materials for compliance with regulatory requirements. Prepare and update divisional SOPs and recommend timely changes to ensure regulatory compliance. Leads and compiles all documents required in submissions, license renewal and annual registrations in line with business plans. Apply knowledge and understanding of the regulatory frameworks, processes, and procedures to maintain compliance of a surgical robotics product portfolio. Monitors and improves regulatory tasks tracking systems effectively. Identify and assess changes in applicable regulations, standards and guidance and perform changes accordingly and maintain the product compliance. Effectively interact with internal stakeholders and external stakeholders (Notified Bodies, distributor, suppliers and other regulatory authorities) on defined matters. Manages post-market activities such as coordination of field action execution, complaint reporting in the region. Face external audits / inspection, coordinate and communicate with external auditors / inspectors for compliance.