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 Corporate Quality Management System (QMS).
Coordination and liaising with Regulatory Agency of India for the submission and follow up of an application.
Coordination with FICCI , CII, MTa I and other Medical Associations.
Qualification – M. Phama/ Masters in Life Sciences
Preferred Experience –
Minimum 3-5 years of working experience in healthcare, preferably in MD Industry
MS Office (focus Excel)
Fluent in oral/written communication (English)
Knowledge of regulatory compliances.