Regulatory Affairs Specialist

Assists in obtaining and maintaining government approval for, medical devices , and related materials. He/she advise project teams on subjects such as premarket regulatory requirements, import-export and labelling requirements, Materiovigilence, or CPCB, & clinical study compliance requirements.

• Check, analyse and implementation of regular updates on scientific information provided by Indian regulators to maintains the strict regulatory compliance as per the latest regulations.
• Preparation, Compilation & Review the technical documents as per MDR-17 & Drugs and Cosmetics Act & Rules and various guidelines published by CDSCO to obtain the Import license for the various Medical Devices.
• Well aware about the applicable guidelines issued by BIS, Legal Metrology, NPPA, DOP, CPCB etc.
• Well aware about Post Approval Changes and related activities.
• Well aware about Materiovigilance Activities.
• Basic understanding about ...