Qa Ra Executive | Freshers | B.tech Bio Technologies

Looking for B.Tech/M.Tech freshers from Biotechnology / Mechanical Engineering Job Title- Associate Medical Writer(QARA) Who are eager to pursue thier career in Regulatory affairs role Roles & Responsibilities:Support preparation and maintenance of medical device regulatory documentation.Assist in preparing Technical Documentation as per EU MDR/IVDR requirements.Support Clinical Evaluation Plans (CEP), CERs, SOA reports, and clinical summaries.Conduct literature searches using PubMed, Google Scholar, Embase, and Cochrane.Assist in PMS activities, including PMS Plans, Reports, and PSURs.Support complaint review, risk assessment, and trend analysis for medical devices.Assist in MDD-to-MDR documentation gap analysis and regulatory compliance checks.Coordinate with project teams and clients for documentation and project-related activities.Maintain accurate project records, trackers, and regulatory documentation.Stay updated on EU MDR, IVDR, FDA, and CDSCO regulatory requirements. .