Assistant Manager - (RA Medical Device)

Responsibilities:

1. Approval of QMS Documentation for Medical Devices.
2. Guidance to draft documents for the Form MD - 12, MD - 7 and MD - 3 for CDSCO submission.
3. Guidance to draft products instruction for use.
4. Guidance to draft Product Labelling.
5. Conducting Training for applicable standards.
6. Review of Risk Management file.
7. Review and finalization of product dossier for USFDA submission
8. Conducting Management Review Meeting.