Alagubalasingaram M V
Summary
An analytical and detail-oriented professional with 3 years of experience in regulatory affairs, clinical data management, and data analysis within the life sciences domain. Skilled in conducting systematic literature reviews, manuscript writing, regulatory documentation, and ensuring global compliance. Highly experienced in working with EU Notified Bodies and US FDA regulations. Proficient in handling complex datasets, quality assessments, and evidence synthesis. Known for strong communication and problem-solving abilities in dynamic, cross-functional environments.
Overview
3
3
years of professional experience
Work History
Senior Medical Writer
Tata Elxsi
Pune
07.2022 - Current
- Developed and executed Clinical Evaluation Plans (CEPs) adhering to MEDDEV 2.7/1 Rev. 4.
- Conducted systematic literature reviews and performed clinical data analysis to support regulatory documentation.
- Authored crucial regulatory documents including LSPS, LSRS, PMCF Plans, PMCF Reports, Clinical Study Reports (CSRs), and clinical protocols.
- Ensured strict adherence to global standards (ISO 13485, ISO 14971, ISO 14155) during the product lifecycle.
- Managed submissions and communication with EU Notified Bodies and supported 510(k) documentation for US FDA.
- Led complaint investigations and CAPA processes to promote continuous quality improvement.
- Served as Subject Matter Expert (SME) for a GenAI tool, enhancing literature writing efficiency.
- Fostered client relationships through timely, customized deliverables.
Education
B.Tech - BioEngineering
SASTRA Deemed University
01.2022
Skills
- Regulatory Expertise:Systematic Literature Review, Regulatory Submissions (EU MDR, US FDA 510(k)), CSR and Protocol Writing, Clinical Reports (Biologics)
- Data & Quality Management:Data Analysis, Quality Assessment, Complaints Handling (CAPA)
- Tools & Databases:PubMed, Embase, EndNote
- Compliance & Standards:ISO 13485, ISO 14971, ISO 14155
- Soft Skills:Cross-functional Team Collaboration, Client Relationship Management, Communication
Awards
- Project Excellence Award – For significant contributions to high-impact regulatory projects.
- Extra Mile Award – Recognized for exceeding expectations and showing proactive initiative.
- TATA Innovator Award – Honored for providing innovative solutions to product development.
Core Competencies
Systematic Literature Review, Regulatory Submissions (EU MDR, US FDA 510(k)), CSR and Protocol Writing, Clinical Reports (Biologics), Data Analysis, Quality Assessment, Complaints Handling (CAPA), PubMed, Embase, EndNote, ISO 13485, ISO 14971, ISO 14155, Cross-functional Team Collaboration, Client Relationship Management, Communication
Timeline
Senior Medical Writer
Tata Elxsi
07.2022 - Current
B.Tech - BioEngineering
SASTRA Deemed University