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
Location: Okhala Phase-1, Delhi 📍
Compensation: As per company norms
🛠️ Key Responsibilities (Job Description)
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.
🎯 Ideal Candidate Profile
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.
📩 How to Apply
If your profile aligns with this role, please share your updated CV with us via email:
⚠️ Important Note: To ensure your application is processed quickly, please clearly mention the Post Name you are applying for in the subject line of your email (e.g., Application for QA/RA Lead – IVD).
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
Location: Okhala Phase-1, Delhi 📍
Compensation: As per company norms
🛠️ Key Responsibilities (Job Description)
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.
🎯 Ideal Candidate Profile
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.
📩 How to Apply
If your profile aligns with this role, please share your updated CV with us via email:
⚠️ Important Note: To ensure your application is processed quickly, please clearly mention the Post Name you are applying for in the subject line of your email (e.g., Application for QA/RA Lead – IVD).