Regulatory Affairs Intern

Location: Noida, Uttar Pradesh | Immediate joining

Gentrac Labs is developing clinical AI for point-of-care and last-mile diagnostics, with our flagship platform HbPRISM for non-invasive haemoglobin and bilirubin assessment using smartphone imaging.

We are looking for a Regulatory Affairs Intern to work directly with the founding team on our clinical development and CDSCO regulatory program. The role has the potential to transition into a full-time position.

What you'll work on

• Supporting CDSCO regulatory submissions and applications for medical devices and SaMD
• Preparing and maintaining regulatory documentation, forms and submission dossiers
• Supporting clinical investigation, test-licence and related regulatory processes
• IEC/CTRI documentation and clinical-study regulatory requirements
• Researching CDSCO regulations, guidance documents and applicable standards
• Coordinating regulatory documentation across clinical, technical and research teams

Who we're looking for

• Recently graduated in Medical Affairs, Regulatory Affairs, Pharmacy, Life Sciences, Biotechnology, Biomedical Engineering or a related field
• Prior hands-on experience with CDSCO filings/applications is strongly preferred
• Familiarity with Medical Devices Rules, CDSCO/SUGAM and medical-device/SaMD regulations
• Strong documentation, research and communication skills
• Comfortable working in an early-stage, hands-on environment
• Immediate availability preferred

This is an opportunity to work closely with the founding team and contribute to the actual regulatory pathway of a clinical AI/medical-device company, with the potential to grow into a full-time Regulatory Affairs role.

Location: Noida

Position: Regulatory Affairs Intern → Full-Time

Joining: Immediate

To apply: Complete this application with your up-to-date CV and a brief note on your relevant CDSCO/regulatory experience.