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.

📌 Qa Ra Executive | Freshers | B.tech Bio Technologies (Noida)
🏢 Saraca Solutions
📍 Noida