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@manasar
I am a Senior Regulatory Affairs engineer advancing global medical device approvals across EU, US, APAC.
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.
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Work history, roles, and key accomplishments
Tata Elxsi Limited
Jan 2023 - Present (2 years 10 months)
Regional lead for dossier preparation and submissions across CEMA and LATAM, ensuring on-time approvals and resolving post-submission queries. Implemented GAP assessments to reduce regulatory timelines and automated documentation workflows using Power BI, VBA macros, and Power Automate.
Implemented Selenium-based test automation within a BDD framework, increasing test coverage and reducing manual regression effort during a 7-month internship.
BGS Global Institute of Medical Sciences and Hospital
Jan 2022 - Feb 2022 (1 month)
Assisted doctors and biomedical engineers in the haemodialysis centre, supporting device operation, maintenance, and clinical workflows to improve equipment uptime and patient care.
Degrees, certifications, and relevant coursework
Bachelor of Engineering, Medical Electronics
Completed Bachelor of Engineering in Medical Electronics at Dr Ambedkar Institute of Technology, Bangalore, graduating in 2022.
Pre-University (PCMB), Physics, Chemistry, Mathematics, Biology
Completed Pre-University (PCMB) at RNS Pre University College, Bangalore, passing in 2018.
Secondary School Certificate (10th Standard), Secondary Education
Completed Secondary School Certificate (10th Standard) at VSS International Public School, Bangalore, in 2016.
Software and tools used professionally
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