Company Description RegTrac is a healthcare regulatory consulting partner that helps organizations manage Global Regulatory Affairs, Quality Management Systems (QMS), and compliance across diverse markets. The team supports companies developing medical devices, cosmetics, and consumer products, providing end-to-end services from regulatory strategy and product registrations to post-market compliance and global representation. With experience across the UK, Europe, the US, Asia, the Middle East, Africa, Australia, and other international regions, RegTrac focuses on practical, “right first time” solutions that reduce risk and accelerate approvals. The company also offers industry-led training programs to build regulatory capability and keep professionals current with evolving regulations, positioning RegTrac as a long-term partner for sustainable business growth.
Role Description This is a full-time, in office role based in Chennai focused on USFDA regulatory activities for medical devices, with a particular emphasis on 510(k) submissions. The role involves preparing, reviewing,



and coordinating regulatory documentation and technical files required for USFDA submissions and other global market approvals. The professional in this position will collaborate with product development, quality, and clinical teams to ensure regulatory requirements are integrated into device design, labeling, risk management, and post-market activities. Daily tasks include tracking regulatory timelines, responding to regulatory authority queries, maintaining compliance with USFDA and international medical device regulations, and supporting audits and inspections. The role also includes monitoring regulatory changes, updating internal procedures, and contributing to regulatory strategies that support timely market access.
Qualifications
Candidates should possess strong foundational knowledge in Medicine and clinical practice relevant to medical devices.
Candidates should possess specialized expe

📌 USFDA || Medical Devices || 510k (Chennai)
🏢 RegTrac
📍 Chennai