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Specialist - Regulatory Affairs - Medical Devices Firm (2-5 yrs)
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.