Officer / Executive / Assistant Manager - Regulatory Affairs (IVD)

About the Role

Meril Diagnostic Pvt. Ltd. in Vapi, Gujarat, is seeking dedicated professionals for multiple Regulatory Affairs positions focused on In Vitro Diagnostic (IVD) products. These roles are key to facilitating the registration and commercialization of innovative diagnostic devices worldwide, ensuring strict adherence to global regulatory standards and compliance.

Primary Duties

The responsibilities vary depending on the level of the position:

• Officer / Executive Level: Develop comprehensive regulatory dossiers and technical documents, draft standard operating procedures and protocols related to validation, stability, and performance studies, assist with risk management paperwork, coordinate compilation and review of submission documents for both domestic and international markets, uphold compliance with ISO 13485 and relevant regulatory requirements, and support product registrations and change control processes throughout the product’s lifecycle.
• Assistant Manager Level: Prepare, review, and oversee regulatory dossiers for local and global markets, lead regulatory submissions adhering to frameworks like EU IVDR, WHO PQ, ANVISA (Brazil), BIS, and other international regulations, collaborate with departments such as QA, R&D, Manufacturing, and Marketing to ensure ongoing regulatory compliance, evaluate product modifications, labeling, artwork, and claims from a regulatory perspective, track regulatory changes worldwide and implement necessary updates, handle regulatory inquiries, audits, and communications with authorities, maintain regulatory licenses and submission records, and guarantee conformity with ISO 13485 and internal quality management systems.

Required Qualifications

• A bachelor's or master's degree in Pharmacy, Life Sciences, Biotechnology, Biomedical Engineering, or related disciplines.
• Experience relevant to Regulatory Affairs within the Medical Device or IVD sectors.
• Practical knowledge of ISO 13485 standards, CE IVDR (EU 2017/746), WHO PQ, ANVISA, BIS, and other global regulatory requirements.
• Expertise in preparing dossiers, technical documentation, and protocols for validation, stability, and performance studies, as well as managing regulatory submissions.
• Strong analytical abilities, excellent documentation skills, coordination experience, and effective communication.

Why Join Meril?

• Engagement with globally respected IVD and Medical Device products.
• Opportunities to contribute toward international regulatory approvals.
• A collaborative environment fostering innovation.
• Build a rewarding career within one of India's premier MedTech organizations.