Website:
gentraclabs.com
Job details:
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.
Click on Apply to know more.