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, on-site 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 expertise in Cardiology for cardiovascular devices and related therapeutic areas.
- Candidates should possess experience in Orthopedic Surgery for devices used in musculoskeletal and joint-related interventions.
- Candidates should possess understanding of Treatment protocols and clinical workflows to align device use with patient care standards.
- Candidates should possess knowledge in Neurology for devices targeting nervous system disorders and neurological interventions.
- Experience with USFDA medical device regulations, including 510(k) pathways, device classification, and pre- and post-market requirements.
- Familiarity with ISO 13485, QMS principles, risk management (ISO 14971), and technical documentation for medical devices.
- Ability to interpret clinical and technical data, prepare clear regulatory submissions, and communicate effectively with cross-functional teams.
- Bachelor’s or Master’s degree in Medicine, Biomedical Engineering, Pharmacy, or a related life science field; advanced or specialty qualification is an advantage.
- Solid attention to detail, analytical skills, and the ability to work in a structured, deadline-driven environment.

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