SMO Clinical Research Private Limited
Website:
smo-india.com
Job details:
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.
Click on Apply to know more.