Manasa R

I am a Senior Engineer in Regulatory Affairs with hands-on experience guiding dossier preparation and submissions across CEMA, LATAM, APAC and US regions. I lead regional teams to deliver timely approvals and actively support post-submission queries and follow-ups.

I have a strong working knowledge of EU MDR 2017/745, ISO 13485 and IEC 62304, and I have prepared technical documentation including design files, design history files, verification & validation records, risk management files, clinical evaluation reports, and post-market surveillance reports.

I have experience with 510(k) and PMA submissions, interacting with authorised agents and notified bodies, supporting surveillance and ISO audits, and performing GAP assessments to reduce timelines and document gaps. I also automate regulatory data and files using Power BI, VBA macros and Power Automate to improve efficiency.

Earlier roles include QA automation projects using Selenium and BDD frameworks and a clinical/biomedical internship supporting haemodialysis operations, giving me practical device knowledge. I am committed to clear communication, continuous learning and contributing measurable regulatory outcomes.