QARA Executive - Active Medical Devices

Job Summary

We are seeking a motivated and detail-oriented QARA Executive with strong hands-on experience in Active Medical Devices and regulatory compliance requirements for India, Europe, and the United States. The candidate should possess practical knowledge of CDSCO regulations, EU MDR requirements, and US FDA 510(k) submissions along with exposure to Quality Management Systems as per ISO 13485.

The role involves preparation and maintenance of regulatory documentation, support for product registrations, implementation of QMS activities, coordination with cross-functional teams, and ensuring compliance throughout the product lifecycle.

Key Responsibilities

· Prepare, review, and maintain regulatory documentation for medical devices.

· Support submissions and approvals under:

o Indian CDSCO Medical Device Rules (MDR) 2017

o EU MDR 2017/745

o US FDA 510(k)

· Prepare and Maintain

o IFU an...