Officer / Executive / Assistant Manager- Regulatory Affairs

Meril; Vapi; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Meril Diagnostic Pvt. Ltd. in India is seeking Regulatory Affairs professionals at Officer to Manager levels to drive dossiers for IVD products and ensure ISO 13485 compliance.

You will prepare regulatory documentation, support international submissions (EU IVDR, WHO PQ, ANVISA, BIS), and collaborate with QA, R&D, and Manufacturing to maintain lifecycle regulatory activities.

Join a leading MedTech organization and contribute to global registrations and product launches.

Qualifications

• Minimum experience in Regulatory Affairs within Medical Device or IVD industries.
• Familiar with regulatory documentation practices and change control.
• Strong analytical, writing, and cross-functional coordination skills.

Responsibilities

• 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.

Skills

Regulatory experience

Documentation

Coordination

Communication

Education

B.Pharm/M.Pharm/Life Sciences/Biotech/Biomedical Eng.

Job description

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

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

Company: Meril Diagnostic Pvt. Ltd.

Are you passionate about bringing innovative 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.

• 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.

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