Primary Role
NeoDx is expanding its diagnostics portfolio and strengthening its clinical and scientific capabilities. As part of our continued growth, we are looking for a motivated and detail-oriented Regulatory Affairs Executive to join our team in Bangalore. This is a full time, on-site role for candidates with 3–4 years of experience in regulatory affairs within the medical devices, IVD, biotechnology, or diagnostics industry. The selected candidate will be responsible for supporting regulatory compliance activities for medical devices, instruments, and IVD products, while collaborating with internal teams, principals, distributors, and

Key Responsibilities
Identify and support appropriate regulatory pathways for product registration based on applicable regulatory requirements.
Review design and development study data, including analytical performance and stability studies, against applicable standards (e.g., ISO, CLSI) and regulatory guidelines.
Review and prepare regulatory documentation in accordance with applicable regulations such as CDSCO, IVDR,



and other relevant requirements.
Assist in the preparation and submission of regulatory applications for product registrations, renewals, and licences through CDSCO, NSWS, EU IVDR, and other applicable regulatory portals.
Track timelines for applications, approvals, renewals, and query responses while maintaining and organizing all related regulatory records, licenses, and certificates.
Coordinate with regulatory authorities, clinical validation partners, and internal cross-functional teams for regulatory activities and submissions.
Assessing overall product risk by assisting in facilitating the use of risk management tools and contributing to the risk management evaluations per ISO 14971.
Assist in preparation of product-related documents including labeling, packaging, Kit inserts, and promotional materials from a regulatory compliance perspective.
Support Post-Market Surveillance (PMS) activities, including comp

📌 Regulatory Affairs Specialist (Bengaluru)
🏢 NeoDx
📍 Bengaluru