Regulatory Affairs Specialist

Industry: Medical Devices
Job Location: Bhatpore, Surat

Job Summary

We are looking for a skilled Regulatory Affairs professional with 36 years of experience in the medical device industry to support global regulatory submissions, product registrations, regulatory compliance, and product lifecycle management.

Key Responsibilities

• Prepare, compile, review, and maintain regulatory submissions and technical documentation for medical devices.
• Manage product registrations, renewals, amendments, and approvals across domestic and international markets.
• Prepare and maintain Technical Files / Regulatory Dossiers and supporting documentation.
• Ensure compliance with applicable regulations and standards, including EU MDR, US FDA, and ISO 13485.
• Support regulatory submissions for new products, product changes, labeling updates, and post-market activities.
• Review product specifications, labeling, IFUs, and product claims from a regulatory perspective.
• Coordinate with R&D, Quality, Clinical, Manufacturing, and other cross-functional teams.
• Track regulatory submissions, authority queries, commitments, approvals, and renewal timelines.
• Prepare responses to Regulatory Authority queries and deficiency letters.
• Monitor changes in regulations, guidance documents, and applicable standards and assess their impact.
• Maintain regulatory records and ensure documentation is accurate, current, and audit-ready.
• Support internal, external, and regulatory audits/inspections.

Candidate Profile

• Bachelor's/Master's degree in Pharmacy, Life Sciences, Biotechnology, Biomedical Engineering, or a related field.
• 36 years of relevant experience in Regulatory Affairs within the medical device industry.
• Good knowledge of EU MDR, US FDA medical device regulations, ISO 13485, and regulatory submission processes.
• Experience in preparation and review of technical documentation/dossiers.
• Understanding of medical device classification, registration, labeling, and change control.
• Strong documentation, analytical, communication, and coordination skills.
• Ability to manage multiple regulatory activities and meet submission timelines.