Job Details - Find Your Perfect Career Opportunity

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.

Key Responsibilities

• 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.
• 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.

Preferred Qualifications

• 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.

Why Join Meril?

• Work with globally recognized IVD and Medical Device products.
• Opportunity to contribute to international regulatory approvals.
• Collaborative and innovation-driven work environment.
• Build your career with one of India's leading MedTech organizations.