3-5 years of experience in Regulatory affairs preferably in the medical device Industry.
Experience in EU MDR, US FDA, other global regulatory requirements. In depth understanding of ISO 13485, CFR 820, CE ISO 14971, certified Internal Auditor.
Knowledge of ISO 13485 Quality management System, ISO 14971 Risk management, IEC 60601-1 , and particular standards.
Knowledge of Preparing Technical Documents for Product Technical File Dossier and Technical file Dossier Submission to the Notified Bodies.
Experience in CE submissions, other global regulatory requirements.
Knowledge of Post market surveillance
Responsible for implementation of ISO 17025, Well versed with the CDSCO registration process and AERB.
