Meril manufactures medical solutions in the form of vascular intervention devices, orthopedic implants, robotics, endo-surgery, ENT products, and in-vitro diagnostics. Within our diverse offerings, we adhere to the best quality of standards in manufacturing, to deliver path-breaking healthcare products to the world.. As a leading healthcare solutions company, we work tirelessly towards the alleviation of human suffering, and improving the quality of life for people across the globe. Our efforts are augmented by a strong commitment to innovation, research, communication, and contemporary distribution avenues.
Post : Officer / Executive / Assistant Manager / Manager – Regulatory Affairs (IVD)
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 ISO 13485, risk management principles, and internal Quality Management Systems.
Candidate Profile
• Bachelor's or Master's degree in Pharmacy, Life Sciences, Biotechnology, Biomedical Engineering, or a related discipline.
• Relevant experience in Regulatory Affairs within the Medical Device or IVD industry.
• Hands-on knowledge of ISO 13485, CE IVDR (EU 2017/746), WHO PQ, ANVISA, BIS, and international regulatory requirements.
• Experience in dossier preparation, technical documentation, validation protocols, stability studies, performance studies, and regulatory submissions.
• Strong analytical, documentation, coordination, and communication skills.
Location : Vapi, Gujarat
Meril Regulatory Affairs : Apply here
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