Industry: Medical Devices
Job Location: Bhatpore, Surat

Job Summary

We are looking for a skilled Regulatory Affairs qualified 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 recent 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.
Valuable 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.

📌 Regulatory Affairs Specialist Surat
🏢 Envision Scientific
📍 Surat