Meghna Roop Raina
@meghnaroopraina
Regulatory Affairs Executive with expertise in medical devices.
IndiaWhat I'm looking for
I am a dedicated Regulatory Affairs Executive with a Master’s degree in Microbiology and extensive experience in the medical devices industry. Currently, I work at Translumina Therapeutics, where I focus on preparing technical documentation and ensuring compliance with EU MDR 2017/745. My role involves compiling technical files, preparing device master files, and maintaining the quality management system, which has honed my skills in regulatory compliance and quality assurance.
Previously, I worked as a Quality Control Microbiologist in the FMCG sector, where I conducted microbiological analyses and ensured product quality through rigorous testing and documentation. My academic background and hands-on expertise in laboratory equipment and chemical handling have equipped me with a solid foundation to excel in regulatory affairs. I am passionate about contributing to the healthcare sector and ensuring that medical devices meet the highest standards of safety and efficacy.
Experience
Work history, roles, and key accomplishments
Executive - Regulatory Affairs
Translumina Therapeutics Private Limited
Jun 2021 - Present (3 years 11 months)
Responsible for the preparation and compilation of technical documentation as per EU MDR 2017/745, including Design Dossier and Device Master File. Conducts gap analysis and maintains the Quality Management System (QMS).
Quality Control Microbiologist
Indo Herbal Products
Aug 2019 - Mar 2021 (1 year 7 months)
Conducted microbiological analysis of raw materials, finished goods, and environmental monitoring. Responsible for calibration of laboratory equipment and documentation of quality reports.
Quality Control Microbiologist
Bajaj Consumer Care Limited
Jan 2019 - Jul 2019 (6 months)
Performed microbiological analysis and quality control checks on raw materials and finished products. Engaged in documentation and maintenance of quality standards.
Intern
Government Medical College, Jammu
Sep 2015 - Mar 2016 (6 months)
Completed a 6-month internship across various departments including Microbiology, Blood Bank, Pathology, and Biochemistry, gaining hands-on experience in medical laboratory practices.
Education
Degrees, certifications, and relevant coursework
DHDolphin Institute, HNBGU
Master of Science, Microbiology
2016 - 2018
Grade: 7.18 CGPA
Completed Master of Science in Microbiology with a CGPA of 7.18. The program included advanced studies in microbiological techniques and research methodologies.
DHDolphin Institute, HNBGU
Bachelor of Science, Microbiology
2013 - 2016
Grade: 70%
Completed Bachelor of Science in Medical Microbiology with a percentage of 70%. The program focused on the study of microorganisms and their impact on human health.
Vishwa Bharti Higher Secondary School
Higher Secondary, Medical Studies
2010 - 2012
Grade: 72.40%
Completed 12th grade with a focus on Medical studies, achieving a percentage of 72.40%. This education laid the foundation for further studies in the medical field.
Divine Light High School
Secondary School, General Studies
2008 - 2010
Grade: 78.80%
Completed 10th grade with a percentage of 78.80%. This education provided a strong academic foundation for future studies.
Tech stack
Software and tools used professionally
Availability
Location
IndiaAuthorized to work in
Job categories
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