Qa Ra Executive | Freshers

Looking for B.tech Bio Technologies Freshers

Who are eager to persue thier career in Ragulatory 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.