Position Overview
Duties & Responsibilities:
Support the APAC regulatory team managing international and domestic filings/registrations, including drafting and compiling of technical files, tender request submission and any audit finding responses.Communicate with headquarter regulatory team on local regulation changes with impact assessment.Assist in communications with global regulatory representatives to assist in filings and responses to inquiries from health authorities.Assist in maintaining product listings and establishment registrations with India regulatory authorities.Familiar with BIS requirements and supporting import/exports for medical devices.Assist in maintaining regulatory databases and summary reports to support management efforts to track and trend filing and registration requirements.Maintain up-to-date knowledge on international and domestic regulatory requirements.Provide regulatory support to the OEM P...