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, MTaI 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.
