Regulatory Affairs Specialist

7 days ago


Delhi, India vueverse. Full time

Role Overview:Responsible for preparing, reviewing, and maintaining regulatory submissions and product registrations to ensure compliance with CDSCO, US FDA, and EU MDR requirements.Key Responsibilities:Prepare and submit regulatory dossiers for product approvals and renewals.Develop and maintain Technical Files, DMR, and DHF .Ensure compliance with CDSCO, FDA 21 CFR Part 820, and EU MDR .Review labeling, IFUs, and promotional materials for compliance.Monitor regulatory updates and standards relevant to medical devices.Support internal and external audits , providing necessary documentation.Collaborate with R&D, QA, and manufacturing teams for regulatory input.Qualifications:B.Pharm / M.Pharm / M.Sc (Regulatory Affairs, Biotechnology, or Life Sciences).Minimum 6 years’ experience in Regulatory Affairs for medical devices.Strong knowledge of device registration process and QMS standards .Experience interacting with Notified Bodies / Regulatory Authorities preferred.



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