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 About Arni Medica Arni Medica Private Limited is an ISO 13485:2016 and ISO 9001:2015 certified medical device and in-vitro diagnostics (IVD) manufacturer based at the Medical Devices Park, Sangareddy (Hyderabad), Telangana. We design and manufacture nephrology, infusion therapy, respiratory care and surgical disposables, and are building a full IVD diagnostics franchise spanning clinical chemistry, electrolyte/ISE, blood gas (ABG), fluorescence immunoassay (FIA) and chemiluminescence immunoassay (CLIA) platforms — backed by Class 100K/10K cleanrooms, EtO sterilization and a CDSCO manufacturing licence (MFG/MD/2023/000942). 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 R&D;, 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.

What We Offer
• A rare opportunity to help build a greenfield IVD diagnostics business from the ground up.
• Modern, ISO 13485 / CDSCO-compliant manufacturing environment with cleanroom infrastructure.
• Direct collaboration with R&D;, Regulatory and senior leadership — visible impact, quick decisions.
• Competitive compensation, commensurate with experience (negotiable; as per industry standards).
• Accelerated career growth in a fast-scaling, export-oriented MedTech company.

How to Apply
Email your CV to [email protected] with the position title in the subject line.

📌 RA Executive – Diagnostics (Hyderabad)
🏢 Arni Medica
📍 Hyderabad