RA Executive – Diagnostics

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, fast decisions. Competitive compensation, commensurate with experience (negotiable; as per industry standards).

Accelerated career growth in a fast-scaling, export-oriented Med. Tech company. How to Apply Email your CV to jobs@arnimedica.com with the position title in the subject line.