Venu Raghuvanshi

Regulatory Affairs Executive @Medorah Meditek Pvt Ltd

Gurugram, IN

Involved in Regulatory Affairs activities for medical devices, including CDSCO licensing, CTRI documentation, and international regulatory submissions- Prepared and maintained Regulatory Technical Files in compliance with EU MDR and global regulatory requirements- Supported Risk Management processes as per ISO 14971:2019, ensuring risk identification, evaluation, and mitigation- Developed and updated Clinical Evaluation Reports (CERs) in line with MEDDEV 2.7/1 Rev. 4 and EU MDR Annex XIV-Collaborated with cross-functional teams to ensure efficient documentation and smooth regulatory approval processes.

GLA University

Master of pharmacy (Pharmaceutics)

GLA University

Bachelor of Pharmacy