Regulatory Affairs

Roles & Responsibilities

• Lead and oversee end-to-end medical device testing as per international standards
• Ensure compliance with risk management processes and design control requirements
• Prepare, review, and maintain technical files, regulatory dossiers, and submission documents
• Manage and evaluate product data for global regulatory approvals
• Coordinate with Engineering, Product Management, Quality, and Marketing teams
• Support product development activities from a regulatory compliance perspective
• Maintain timelines and ensure documentation readiness for audits and submissions

Qualification

• Degree in Pharmacy, Biomedical Engineering, Life Sciences, or a related discipline

Experience

• Experience in Regulatory Affairs within the medical device industry
• Exposure to global regulatory submissions and technical documentation preferred

Skills

• Strong knowledge of medical device regulations and regulatory documentation
• Familiarity with ISO 13485, EU MDR, US FDA, and global regulatory requirements
• Excellent communication, documentation, and cross-functional coordination skills
• Detail-oriented, proactive, and capable of working in a fast-paced environment

About the Organisation

Meril is a globally recognized medical device company known for developing innovative, high-quality healthcare solutions across multiple therapeutic areas. With a strong international presence, Meril offers professionals hands-on exposure to global regulatory frameworks, cutting-edge MedTech products, and long-term career growth in a dynamic and fast-growing organization.