Senior Manager

Responsibilities

• Prepare, review, and maintain regulatory dossiers and technical documentation for domestic and international markets
• Support submissions for EU IVDR, WHO PQ, ANVISA, and other applicable regulatory frameworks
• Coordinate with QA, R&D, Manufacturing, and Marketing to ensure regulatory compliance and meet submission requirements
• Review product changes, labeling, claims, and supporting documents from a regulatory perspective
• Monitor updates in global regulations and support the implementation of applicable changes
• Assist in responses to regulatory queries, audits, inspections, and communications with external agencies
• Maintain organized regulatory records, licenses, registrations, and submission trackers
• Ensure compliance with internal quality management systems and applicable industry standards

Requirements

• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biotechnology, Biomedical Engineering, or a related discipline
• 2–3 years of relevant experience in Regulatory Affairs within the medical device or IVD industry
• Working knowledge of EU IVDR, WHO PQ, Brazil ANVISA, and other international medical device regulations
• Familiarity with technical documentation, submissions, labeling, and change management processes
• Understanding of ISO 13485, risk management principles, and regulatory documentation practices
• Strong documentation, analytical, coordination, and verbal/written communication skills

About the Company

Founded in 2006, Meril is a global medical device company dedicated to the innovation, design, and development of state-of-the-art healthcare solutions. We manufacture a diverse range of products, including vascular intervention devices, orthopaedic supplements, in-vitro diagnostics, endo-surgery, and ENT products. Headquartered in India with a global presence in over 100 countries, Meril is committed to improving the quality of human life through advanced R&D and excellence in manufacturing.