Job DescriptionWe're Hiring | Regulatory Affairs Professionals (IVD Industry) Position: Officer / Executive / Assistant Manager / Manager – Regulatory Affairs (IVD) Location: Vapi, Gujarat Company: Meril Diagnostic Pvt. Ltd. Are you passionate about bringing cutting-edge diagnostic products to global markets while ensuring regulatory compliance? Join our Regulatory Affairs team and play a key role in supporting the registration and commercialization of world-class In Vitro Diagnostic (IVD) products. Open Positions Officer – Regulatory Affairs Executive – Regulatory Affairs Assistant Manager – Regulatory Affairs Key Responsibilities Officer / Executive – Regulatory Affairs Prepare regulatory dossiers and technical documentation for IVD products. Draft SOPs, validation protocols, stability study protocols, and performance study protocols. Support risk management documentation and product lifecycle regulatory activities. Coordinate dossier compilation and document review for domestic and international submissions.



Ensure compliance with ISO 13485 and applicable regulatory requirements. Support regulatory documentation, product registrations, and change control activities. Assistant Manager / Manager – Regulatory Affairs Prepare, review, and maintain regulatory dossiers and technical documentation for domestic and global markets. Lead and support regulatory submissions for EU IVDR, WHO PQ, ANVISA (Brazil), BIS , and other international regulatory frameworks. Collaborate with QA, R&D;, Manufacturing, and Marketing to ensure regulatory compliance throughout the product lifecycle. Review product changes, labeling, artwork, claims, and technical documentation from a regulatory perspective. Monitor changes in global regulations and implement applicable regulatory updates. Respond to regulatory queries, audits, inspections, and communications with regulatory authorities. Maintain regulatory licenses, registrations, submission trackers, and compliance records. Ensure adherence to

📌 Officer / Executive / Assistant Manager- Regulatory Affairs (Vapi)
🏢 Meril
📍 Vapi