Job Description We're Hiring | Regulatory Affairs Professionals (IVD Industry)
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n Position: Officer / Executive / Assistant Manager / Manager – Regulatory Affairs (IVD)
n Location: Vapi, Gujarat
n Company: Meril Diagnostic Pvt. Ltd.
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nAre you passionate about bringing cutting-edge 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.
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nOpen Positions
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- Officer – Regulatory Affairsn
- Executive – Regulatory Affairsn
- Assistant Manager – Regulatory Affairsn
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n Key Responsibilities
n Officer / Executive – Regulatory Affairs
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- 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
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n Assistant Manager / Manager – Regulatory Affairs
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- 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