Vinaya

Senior Medical Writer @Tata Elxsi

Pune, IN

Medical Writing Expertise • Independently authored and delivered EU MDR-compliant documents (CERs, CEPs, SSCPs, PSUR, PMCF plans and reports, CRF) in line with MedDev 2.7/1 Rev. 4 and EU MDR requirements. • Conducted clinical evaluations and prepared regulatory supporting documents for submissions. • Performed literature reviews in assigned therapeutic areas and provided scientific input across cross-functional teams. Analyzed complaint-handling data (Excel) including CAPAs, SCARs, and FSCAs to support PMS, risk management, and device safety reporting.• Streamlined reviewer feedback integration to efficiently finalize clinical and regulatory deliverables.• Mentored and provided technical guidance to junior and new medical writers, enhancing team performance and document quality.SQA & Audit Expertise• Performed comprehensive QC checks (copyediting, proofreading, data verification against TFLs) to ensure accuracy, consistency, and regulatory compliance.• Supported Software Quality Assurance (SQA) activities and served as an audit observer, maintaining documentation integrity and regulatory readiness.• Assisted project managers in achieving monthly SQA metrics and compliance goals.• Analyzed complaints data to identify trends and support risk assessment initiatives.

Shivaji University

Msc

Sangmeshwar college of Science

12th

Little Flower High School

10th

Symbiosis Centre for Distance Learning

Diploma in Clinical research

VGS college of Biotechnology

Bsc