Live opening · Posted 16 days ago
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About the role
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Regulatory Affairs Intern → Full-Time Opportunity
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.
Work arrangement
No
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