QA/RA Lead (IVD Rapid & Biochemistry)

Bharrgava TetraMedEx; Dadri; On-site; INR 4,000,000 - 7,000,000; Full time

Job summary

Bharrgava TetraMedEx is seeking a seasoned QA/RA Lead (IVD Rapid & Biochemistry) to drive regulatory strategy and quality systems across rapid tests and biochemistry reagents. The role requires 10–15 years of relevant industry experience, with strong leadership and documentation expertise.

The candidate will manage CDSCO submissions and international regulatory affairs, ensure compliance with ISO 13485 and GMP, and oversee audits, CAPA, and tech transfer activities to support high‑quality

Qualifications

• 10–15 years of relevant industry experience.
• Deep knowledge of QA/RA for IVD/medical devices.
• Expertise in ISO 13485 and GMP standards.
• Experience with CDSCO submissions and regulatory audits.

Responsibilities

• Lead compilation, submission, and management of technical dossiers for manufacturing and import licenses with CDSCO and global regulators.
• Interpret and implement updates to MDR, CDSCO guidelines, and international regulations for IVD products.
• Act as primary contact for regulatory authorities, handling audits, inspections, and inquiries.
• Maintain, enforce, and improve the QMS in alignment with ISO 13485 and GMP.
• Plan and execute internal, vendor, and third‑party regulatory audits; drive CAPA to closure.
• Oversee tech transfer, process validation, equipment qualification, and batch release for rapid kits and biochemistry reagents.
• Manage market vigilance including customer complaints, OOS investigations, and recalls if required.

Skills

Leadership

Documentation

Risk management

Regulatory affairs

QMS management

Audits & CAPA

Education

B.Tech/M.Tech in Biotechnology or Biomedical Engineering; Master’s in Biochemistry / Microbiology / Pharmacy

Job description

Are you a seasoned Quality Assurance and Regulatory Affairs professional with a deep understanding of In Vitro Diagnostics (IVD)? We are looking for a strategic and hands-on leader to drive our QA/RA operations for the IVD Rapid & Biochemistry segments.

If you have a proven track record of managing compliance, regulatory approvals, and quality systems in the medical device/IVD space, we want to hear from you!

Role Overview

Position: QA/RA Lead (IVD Rapid & Biochemistry)

Experience: 10–15 years of relevant industry experience

Regulatory Affairs (RA) & Compliance:

Product Registrations: Lead the compilation, submission, and management of technical dossiers for manufacturing and import licenses with CDSCO (Form MD-5/7/9/15) and other global regulatory bodies.

Regulatory Strategy: Interpret and implement updates related to the Medical Device Rules (MDR), CDSCO guidelines, and relevant international regulations for IVD products.

Liaison: Act as the primary point of contact for regulatory authorities, handling audits, inspections, and queries seamlessly.

Quality Assurance (QA) & QMS Management:

QMS Implementation: Maintain, enforce, and continuously improve the Quality Management System (QMS) in strict alignment with ISO 13485 and GMP standards.

Audits & Assessments: Plan and execute internal, vendor, and third-party regulatory audits. Drive corrective and preventive actions (CAPA) to closure.

Process & Product Quality: Oversee tech transfer, process validation, equipment qualification, and stable batch release mechanisms for both rapid kits and biochemistry reagents.

Market Vigilance: Manage customer complaints, out-of-specification (OOS) investigations, and adverse event reporting/recalls if required.

Education: B.Tech/M.Tech in Biotechnology, Biomedical Engineering, or Master’s in Biochemistry / Microbiology / Pharmacy.

Expertise: Deep core knowledge of rapid diagnostic kits (lateral flow assays) and clinical biochemistry reagents.

Skills: Strong leadership acumen, exceptional documentation skills, and a proactive approach to risk management.