Company Overview
RegTrac is a leading healthcare regulatory partner specializing in Global Regulatory Affairs, Quality Systems, and Compliance for Medical Devices, Cosmetics, and Consumer Products. With expertise in navigating regulatory requirements across diverse markets, RegTrac empowers MedTech companies to innovate and expand globally while ensuring regulatory compliance. Our comprehensive services include strategic insights, compliance mastery, and training programs in Regulatory Affairs to support businesses in achieving success.

Role description
We are seeking a highly motivated Regulatory Affairs Associate to join our dynamic team in Chennai. In this role, you will play a critical part in ensuring regulatory compliance for our medical device products throughout their lifecycle. You will collaborate with cross functional teams, including R&D;, Quality Assurance, and Marketing, to support product development, regulatory submissions, and global market access.

Key Responsibilities
Prepare and submit regulatory submissions for medical devices including 510(k)s,



and eSTAR applications, ensuring compliance with FDA and international regulatory standards.
Conduct comprehensive reviews of product labeling, promotional materials, and technical documentation to ensure alignment with regulatory guidelines.
Monitor, interpret, and communicate changes in global regulatory requirements and trends, providing strategic guidance to internal stakeholders.
Establish and maintain effective communication with regulatory agencies, including the US FDA, to address inquiries, audits, and information requests.
Develop and implement regulatory strategies for recent product development, market entry, and post-market surveillance activities.
Collaborate with cross-functional teams to conduct regulatory compliance training and foster a culture of regulatory awareness within the organization.
Foster a dynamic working relationship with RegTrac Clients.

Required Qualifications
Master’s degr

📌 Regulatory Affairs Associate (Chennai)
🏢 RegTrac
📍 Chennai