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05/01 Sunil Dsouza
Recruiter at Angel HR Executive Search & Solutions

Views:178 Applications:41 Rec. Actions:Recruiter Actions:2

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

Delhi/Delhi NCR Job Code: 878848

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

Women-friendly workplace:

Maternity and Paternity Benefits

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