Job Description

We're Hiring | Regulatory Affairs Professionals (IVD Industry)

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Position: Officer / Executive / Assistant Manager / Manager – Regulatory Affairs (IVD)

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Location: Vapi, Gujarat

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Company: Meril Diagnostic Pvt. Ltd.

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Are 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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Open Positions

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- Officer – Regulatory Affairs
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- Executive – Regulatory Affairs
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- Assistant Manager – Regulatory Affairs
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Key Responsibilities

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Officer / Executive – Regulatory Affairs

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- Prepare regulatory dossiers and technical documentation for IVD products.
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- Draft SOPs, validation protocols, stability study protocols, and performance study protocols.
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- Support risk management documentation and product lifecycle regulatory activities.
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- Coordinate dossier compilation and document review for domestic and international submissions.
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- Ensure compliance with ISO 13485 and applicable regulatory requirements.
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- Support regulatory documentation, product registrations, and change control activities.
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Assistant Manager / Manager – Regulatory Affairs

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- Prepare, review, and maintain regulatory dossiers and technical documentation for domestic and global markets.
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- Lead and support regulatory submissions for EU IVDR, WHO PQ, ANVISA (Brazil), BIS , and other international regulatory frameworks.
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- Collaborate with QA, R&D;, Manufacturing, and Marketing to ensure regulatory compliance throughout the product lifecycle.
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- Review product changes,



labeling, artwork, claims, and technical documentation from a regulatory perspective.
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- Monitor changes in global regulations and implement applicable regulatory updates.
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- Respond to regulatory queries, audits, inspections, and communications with regulatory authorities.
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- Maintain regulatory licenses, registrations, submission trackers, and compliance records.
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- Ensure adherence to ISO 13485 , risk management principles, and internal Quality Management Systems.
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✅ Preferred Qualifications

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- Bachelor's or Master's degree in Pharmacy, Life Sciences, Biotechnology, Biomedical Engineering , or a related discipline.
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- Relevant experience in Regulatory Affairs within the Medical Device or IVD industry .
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- Hands-on knowledge of ISO 13485, CE IVDR (EU 2017/746), WHO PQ, ANVISA, BIS , and international regulatory requirements.
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- Experience in dossier preparation, technical documentation, validation protocols, stability studies, performance studies, and regulatory submissions.
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- Strong analytical, documentation, coordination, and communication skills.
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Why Join Meril?

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

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Know someone who would be a great fit? Like, Share, or Tag them in the comments!

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#Hiring #RegulatoryAffairs #IVD #MedicalDevices #Diagnostics #EUIVDR #WHOPQ #ANVISA #ISO13485 #MedicalDeviceJobs #Biotechnology #LifeSciences #HealthcareJobs #VapiJobs #GujaratJobs #Meril #CareerOpportunity

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