Lead Reviewer – FDA 510(k) Third Party Review Program

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 opportunity 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)
• Strong understanding of FDA device classification, product codes, and regulatory pathways
• Experience evaluating substantial equivalence and regulatory evidence
• Ability to independently assess technical documentation and identify gaps
• Familiarity with quality systems and regulatory expectations (e.g., 21 CFR 820, ISO 13485)
• Ability to operate as an independent evaluator within defined regulatory frameworks

Preferred Qualifications

• Experience with regulatory consultancies or global medical device manufacturers
• Exposure to multiple Class I and Class II device categories
• Familiarity with EU MDR and global regulatory frameworks
• Advanced degree in biomedical, mechanical, or related engineering/scientific discipline

Why This Role

This is a unique opportunity to be part of an FDA-recognized Third-Party Review Unit and play a key role in shaping how independent regulatory evaluations are conducted from India for global medical device manufacturers.

Engagement Structure

• Initial part-time engagement (transition phase)
• Opportunity to transition into a full-time leadership role as review volumes grow

• If this aligns with your experience, or if you know someone suitable, please reach out directly.