We are currently seeking a highly motivated and experienced professional in Regulatory Affairs specializing in Medical Devices to join our team. Job Titles: Senior Executive and Assistant Manager - Regulatory Affairs Experience: 3 to 9 years Location: Andheri east, Mumbai Working Days: 6 days (Mon-Sat) - WFO Responsibilities: 1. Dossier collation and submission across the globe for the medical devices for all of the above segments. 2. Query handling and liase with various Ministries of Health for the approvals of the devices. 3. Coordination with R&D, Plant Quality Assurance/Regulatory Affairs department for the collation of the dossiers. 4. Communication with distributors/consultants across the globe to get approvals for the devices. 5. Coordination with the International Sales Team for the registrations in their respective countries. 6. Update and maintain the documentation for the submissions at our end and maintain all records. 7. Maintaining and monitoring the QMS documentation and Preparing for Audits as per individual countries requirement.