Regulatory Affairs Lead

Our client is one one of the pioneers and trusted surgical solutions and medtech companies. They export to more than 80 countries worldwide and collaborate with hospitals, governments, and healthcare systems worldwide to strengthen surgical ecosystems and improve patient lives.

Primary Role :

The QA & Regulatory Affairs Manager leads and oversees all regulatory and quality assurance activities within the company, ensuring that all products comply with local and international medical device regulations.

A core aspect of this position is to build and implement a full Quality Management System (QMS) compliant with ISO 13485 : 2016, and to ensure regulatory readiness for global markets including India (CDSCO), US (FDA 510(k)), and EU (MDR CE marking).

Key responsibilities :

The role is responsible for developing and executing regulatory strategies, managing submissions and approvals, and maintaining strong relationships with health authorities, notified bodies, and certification agencies to support product launches and lifecycle management.

• Quality Management System (QMS) : ISO 13485 : 2016;

risk management (ISO 14971)

Candidate Profile

Education & Experience