Job Description
Job Title: Regulatory Affairs Executive Diagnostics
Location: Hyderabad, India
Department: Regulatory Affairs
Experience: 2 5 years (RA in diagnostics or medical devices; freshers considered for junior roles)
Employment Type: Full-time, on-site
Role Overview
The RA Executive will support product registrations, dossier preparation, technical documentation and ongoing regulatory compliance for diagnostics products in domestic and export markets, coordinating with RD, QA, manufacturing and commercial teams to maintain timely submissions.
Key Responsibilities
- Prepare and review regulatory dossiers and technical files for India (CDSCO) and export markets.
- File and track applications via the CDSCO SUGAM portal MD-05/MD-09 (manufacturing) and MD-13/MD-14/MD-15 (import) as applicable.
- Maintain Device Master Files (DMF), submission trackers and regulatory correspondence.
- Coordinate responses to authority queries and submission deficiencies.
- Review labels, IFUs and product claims for compliance; issue / coordinate Free Sale Certificates (CFS) for exports.
- Monitor regulatory changes (CDSCO MDR 2017, ISO 13485, ISO 14971, EU IVDR, FDA) and assess business impact.
Desired Candidate Profile
- Education: B.Pharm / M.Pharm, M.Sc / B.Sc (Life Sciences, Biotech, Microbiology) or B.Tech; RA PG diploma a plus.
- Experience: 2 5 years of RA experience in diagnostics or medical devices.
Technical Skills Keywords
CDSCO, SUGAM portal, Medical Device Rules 2017 (MDR 2017), MD-05 / MD-09 / MD-13 / MD-14 / MD-15, ISO 13485:2016, ISO 14971, technical file / DMF / DHF, IVD registration, labelling IFU compliance, Free Sale Certificate (CFS), post-market surveillance, 21 CFR Part 11 / FDA, EU IVDR / CE awareness.
Preferred / Good to Have
- Export-dossier and country-specific registration experience.
- IVD-specific (vs general device) regulatory experience.
- ISO 14971 risk-file and regulatory-intelligence tool exposure.