Specialist - Regulatory Affairs - Medical Devices Firm

Kindly find the below JD for your reference

- Ensures compliance with current and new regulations within Indian and (Global Business Unit) GBU Guidelines for Regulatory Affairs.

- Ensure compliance to all Market requirements and company policies and procedures regarding submissions and other requirements for market approval of medical devices products.

- Is responsible for ensuring the timely submission of all renewal and new product applications of all products and ensuring the relevant licenses are obtained.

- Review of product registration documents for accuracy and completeness as required

- Manages a system for the intimation and appropriate follow up of field actions

- Report all recalls to the Health Authorities.

- Ensure Compliance to (Quality Management System) QMS requirements.

Maria