Location: Hyderabad (Hybrid) | Part-time → Full-time transition

About SMO India
SMO India is India's first and only FDA-recognized Third-Party Review Organization under the 510(k) program, authorised to conduct independent reviews of eligible Class I and Class II medical devices. As we expand this vertical, we are strengthening our reviewer capability to support FDA-aligned evaluations and regulatory readiness activities.

Role Overview
We are seeking a Lead Reviewer with strong FDA 510(k) experience to support independent review activities under the Third-Party Review Program.
This role will initially be part time during a transition phase, with the chance to move into a full-time leadership position as review volumes increase.
The role is central to maintaining the quality, consistency, and regulatory integrity of all review activities conducted under the Third-Party Review framework.

Key Responsibilities
• Conduct independent reviews of 510(k) submissions in alignment with FDA expectations
• Evaluate intended use, device characteristics, and substantial equivalence




• Map devices to FDA product codes and assess classification and eligibility
• Review technical documentation for completeness, accuracy, and regulatory alignment
• Generate structured review reports and recommendations for submission to FDA
• Interpret FDA guidance and apply it within review frameworks
• Support regulatory readiness assessments across USFDA, CDSCO, and MHRA requirements
• Act as the lead reviewer within the Third-Party Review Unit, providing oversight on review quality, consistency, and alignment across evaluations
• Contribute to SOP development, reviewer processes, and quality system strengthening
• Ensure strict adherence to conflict-of-interest and independence requirements

Required Qualifications
• Demonstrated hands-on experience with FDA 510(k) submissions (authoring and/or review)
• Robust understanding of FDA device classification, product codes, and regulatory pathwa

📌 Reviewer – FDA 510(k) Third Party Review Program (Hyderabad)
🏢 SMO India
📍 Hyderabad