Rohit Gurjar

Senior Regulatory Affairs Executive @Halma plc

Bangalore, IN

Regulatory Compliance: Staying up-to-date with the latest regulatory guidelines and requirements related to medical equipment manufacturing.Ensure products meet the necessary standards and obtain appropriate approvals for market clearance or CE marking (in Europe) before distributionDocumentation and Submissions: Preparing and submitting regulatory documentation to regulatory authorities, such as the FDA (U.S. Food and Drug Administration), European Medicines Agency (EMA), or other relevant regulatory bodies in different countries. This includes technical files, design dossiers, clinical data, and other supporting documents.Post-Market Surveillance: Monitoring the performance of medical devices once they are on the market and reporting adverse events or safety concerns to the regulatory authorities as required. This involves handling post-market surveillance activities and ensuring compliance with post-market surveillance plans.Quality Management: Collaborating with the Quality Assurance team to ensure that the manufacturing processes and quality control procedures adhere to regulatory standards and Good Manufacturing Practices (GMP).Regulatory Updates: Keeping the company informed about changes in regulations, guidelines, or standards that may impact the manufacturing and distribution of medical equipment. Implementing necessary changes to ensure ongoing compliance.Audit Preparation: Ensure preparedness with regulatory framework during inspections, audits, or requests for additional information related to medical equipment regulatory submissions.Cross-Functional Collaboration: Collaborating with various internal departments, including research and development, engineering, marketing, and sales, to ensure a comprehensive understanding of product specifications and regulatory requirements.

VTU HSIT

Engineer's Degree