Job Description We're Hiring | Regulatory Affairs Professionals (IVD Industry) n Position: Officer / Executive / Assistant Manager / Manager – Regulatory Affairs (IVD) n Location: Vapi, Gujarat n Company: Meril Diagnostic Pvt. Ltd. n Are you passionate about bringing innovative 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. n Open Positions n n Officer – Regulatory Affairs n Executive – Regulatory Affairs n Assistant Manager – Regulatory Affairs n n Key Responsibilities n Officer / Executive – Regulatory Affairs n n Prepare regulatory dossiers and technical documentation for IVD products. n Draft SOPs, validation protocols, stability study protocols, and performance study protocols. n Support risk management documentation and product lifecycle regulatory activities. n Coordinate dossier compilation and document review for domestic and international submissions. n Ensure compliance with ISO 13485 and applicable regulatory requirements. n Support regulatory documentation, product registrations, and change control activities. n n Assistant Manager / Manager – Regulatory Affairs n n Prepare, review, and maintain regulatory dossiers and technical documentation for domestic and global markets. n Lead and support regulatory submissions for EU IVDR, WHO PQ, ANVISA (Brazil), BIS, and other international regulatory frameworks. n Collaborate with QA, R&D;, Manufacturing, and Marketing to ensure regulatory compliance throughout the product lifecycle. n Review product changes, labeling,



artwork, claims, and technical documentation from a regulatory perspective. n Monitor changes in global regulations and implement applicable regulatory updates. n Respond to regulatory queries, audits, inspections, and communications with regulatory authorities. n Maintain regulatory licenses, registrations, submission trackers, and compliance records. n Ensure adherence to ISO 13485, risk management principles, and internal Quality Management Systems. n n Preferred Qualifications n n Bachelor's or Master's degree in Pharmacy, Life Sciences, Biotechnology, Biomedical Engineering, or a related discipline. n Relevant experience in Regulatory Affairs within the Medical Device or IVD industry. n Hands-on knowledge of ISO 13485, CE IVDR (EU 2017/746), WHO PQ, ANVISA, BIS, and international regulatory requirements. n Experience in dossier preparation, technical documentation, validation protocols, stability studies, performance studies, and regulatory submissions. n Strong analytical, documentation, coordination, and communication skills. n n Why Join Meril? n n Work with globally recognized IVD and Medical Device products. n Prospect to contribute to international regulatory approvals. n Collaborative and innovation-driven work environment. n Build your career with one of India's leading MedTech organizations. n n Apply Here: n Know someone who would be a great fit? Like, Share, or Tag them in the comments! n #Hiring #RegulatoryAffairs #IVD #MedicalDevices #Diagnostics #EUIVDR #WHOPQ #ANVISA #ISO13485 #MedicalDeviceJobs #Biotechnology #LifeSciences #HealthcareJobs #VapiJobs #GujaratJobs #Meril #CareerOpportunity

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