Regulatory Affairs Executive - Navi Mumbai, India - METSL

METSL

Verified Company

Navi Mumbai, India

2 weeks ago

Posted by:

Deepika Kaur

beBee Recuiter

Description

We have job opportunity for the position of Regulatory Affairs Executive in our leading manufacturing company.

Location:

Navi Mumbai

Experience:

2 to 3 yrs

Gender:

Male/Female

Maintain regulatory files. Maintain and update regulatory authorizations, such as IDEs, Medical device licenses, and CE dossiers for certifications etc.

Documenting technical file for ISO 9001:2005 and Implementing compliance to performance of Medical Device
Product registrations with supervision, evaluate, prepare and submit medical registrations.
Reviewing all quality policies and procedures with standard regulatory requirements.
Successfully implemented quality procedures related to medical device standard
ISO1348
Ensure compliance with corporate regulatory processes and internal SOP's
Looking over the non conformities of the medical devices and resolving the CAPA procedures
Handling queries and follow up with regulatory bodies.
Support external regulatory agency audits, providing regulatory input to minimize potential for findings of noncompliance.
Conducting internal audits.