? We'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 creative 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 reco

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