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 exper

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