REGULATORY AFFAIRS PROFESSIONAL | IVD / DIAGNOSTICS

Role Purpose

The role will be responsible for managing regulatory registrations, approvals, submissions and compliance for IVD products in India and supporting regulatory requirements for new and existing products.

Key Responsibilities

Regulatory Submissions & Approvals

• Manage regulatory submissions and product registration activities for IVD analyzers, reagents, kits and diagnostic products .
• Prepare, review and maintain regulatory dossiers and supporting documentation.
• Coordinate with regulatory authorities for applications, queries, clarifications and approvals.
• Ensure timely renewal and maintenance of licenses, registrations and certificates.

CDSCO / Indian Regulatory Compliance

• Handle regulatory requirements related to CDSCO, Medical Device Rules (MDR) 2017 and applicable Indian regulations .
• Support classification and regulatory pathway assessment for new IVD products.
• Manage regulatory correspondence and maintain complete documentation for inspections/audits.

Product Registration & Compliance

• Review product technical documentation, specifications, labels, IFUs and other regulatory documents.
• Coordinate with R&D, Quality, Manufacturing, Clinical, Marketing and Supply Chain teams for regulatory submissions.
• Ensure products remain compliant throughout their lifecycle.
• Support change-control, product modifications and regulatory impact assessments.

International Regulatory Exposure

• Support registrations and regulatory submissions for international markets, wherever applicable.
• Coordinate with distributors/partners and overseas regulatory teams for product registration requirements.

Regulatory Intelligence

• Monitor changes in IVD/medical-device regulations, guidelines and regulatory requirements .
• Assess regulatory impact of new regulations and communicate requirements internally.

Candidate Profile

• Bachelor's/Master's degree in Pharmacy, Life Sciences, Biotechnology, Microbiology, Biochemistry, Biomedical Science or related field .
• 5–12 years of Regulatory Affairs experience specifically within IVD / Diagnostics / Medical Devices.
• Strong working knowledge of CDSCO, MDR 2017 and IVD regulatory requirements .
• Experience with regulatory submissions, product registration, licensing and compliance .
• Good documentation, coordination and stakeholder-management skills.

Mandatory Experience

✅ IVD / Diagnostic industry background
✅ Regulatory Affairs / Regulatory Compliance
✅ CDSCO / MDR 2017 exposure
✅ Product registration / licensing
✅ Experience with diagnostic reagents, kits and/or analyzers