? 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 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.

? 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 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.

? Apply Here: https://zfrmz.in/1MGIjCVWV08kVSRj76CF

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