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

Global Third Party Review Private Limited (GTPR)

Location: Hyderabad, Telangana (on-site)

Employment Type: Full-time, 1-year contract (renewable based on performance)

ABOUT US

GTPR is an independent third-party review organization recognized under the U.S. FDA’s 510(k) Third Party Review Program. We review premarket notification [510(k)] submissions for medical device manufacturers worldwide. We work independently and impartially, to FDA’s standards. We’re building a small, high-calibre review team in Hyderabad and are looking for an experienced Lead Reviewer to lead technical reviews from start to finish.

THE ROLE

As Lead Reviewer, you’ll own the technical review of 510(k) submissions assigned to GTPR. You’ll assess substantial equivalence, prepare FDA-compliant review memoranda and recommendations, and make sure every review meets FDA requirements, GTPR’s Quality Management System, and the program’s timelines.

KEY RESPONSIBILITIES

- Lead full technical reviews of Traditional, Special and Abbreviated 510(k) submissions under the FDA 3P510(k) Program
- Perform acceptance/Refuse-to-Accept (RTA) and eSTAR completeness checks against current FDA policy and guidance
- Evaluate substantial equivalence: intended use, technological characteristics, predicate comparison, and performance data
- Review device descriptions, labeling, biocompatibility, sterilization, shelf life, electrical safety and EMC, software, cybersecurity, bench, animal and clinical performance data, as applicable
- Assess compliance with recognized consensus standards (e.g., ISO 14971, ISO 10993, IEC 60601 series, IEC 62304, ISO 11135/11137) and device-specific FDA guidance documents
- Draft deficiency letters and Additional Information (AI) requests, and manage interactive review with submitters




- Prepare complete review memoranda and recommendations for submission to FDA/CDRH within program timelines
- Coordinate with FDA review staff on clarifications, questions and post-recommendation follow-ups
- Mentor and guide reviewers, and conduct peer and QA reviews of their work
- Follow GTPR’s QMS, SOPs, document control, data integrity and record-retention requirements
- Maintain strict confidentiality of all submitter information, and declare and manage any potential conflicts of interest
- Support internal audits, FDA assessments, and continuous improvement of review processes and templates
- Stay current with FDA regulations, guidance updates and program changes affecting 510(k) review

MANDATORY REQUIREMENTS

- Hands-on 510(k) experience is a MUST: preparing, reviewing or managing 510(k) submissions (as an FDA reviewer, third-party reviewer, or industry regulatory affairs professional)
- Bachelor’s or Master’s degree in Biomedical Engineering, Electrical/Electronics Engineering, Mechanical Engineering, Life Sciences, Pharmacy, or a related scientific or technical discipline
- Strong working knowledge of 21 CFR Part 807 (Subpart E), 21 CFR Part 820 / QMSR, and FDA’s 510(k) and substantial equivalence guidance
- Ability to write explicit, well-reasoned technical review documents in English
- No current financial, employment or consulting relationships with medical device manufacturers or submitters that would create a conflict of interest (to be declared and verified)




- Willingness to work full-time from our Hyderabad office

PREFERRED QUALIFICATIONS

- 5+ years of experience in medical device regulatory affairs, design/development, testing or quality
- Prior experience as an FDA reviewer or with a recognized Third-Party Review Organization
- Experience across multiple device panels/specialties (e.g., cardiovascular, general hospital, orthopedic, radiology, dental, SaMD/digital health)
- Familiarity with eSTAR, ISO 13485, and EU MDR / CDSCO MDR 2017
- Experience leading or mentoring technical teams

TRAINING & BACKGROUND VERIFICATION (MANDATORY)

- All required FDA training will be provided by GTPR. Completing all FDA-mandated training is compulsory for the role.
- An FDA background check will be conducted during the training period. Passing the background check is compulsory: continued employment and appointment as Lead Reviewer depend on clearing it.
- Candidates must sign GTPR’s Confidentiality/Non-Disclosure Agreement and Conflict of Interest declaration before starting.

CONTRACT TERMS

- Full-time, fixed-term contract of 1 (one) year
- Renewal or extension based on performance, business needs and continued compliance with FDA program requirements
- Competitive compensation, commensurate with experience

WHY JOIN GTPR

- Lead independent FDA 510(k) reviews from India for a global client base
- Work directly within an FDA-recognized review program
- Full FDA training and structured professional development
- A small, focused team where your expertise shapes how the organization grows

HOW TO APPLY

Apply through LinkedIn, or send your CV to [email address] with the subject line “Lead Reviewer – 510(k)”. Please include a short summary of your 510(k) experience: number of submissions, device types, and your role in each.

GTPR is an equal opportunity employer.

📌 Lead Reviewer – FDA 510(k) Third Party Review Program (Hyderabad)
🏢 Global Third Party Review
📍 Hyderabad