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.
- Robust documentation, analytical, communication, and coordination skills.
- Ability to manage multiple regulatory activities and meet submission timelines.

📌 Regulatory Affairs Specialist (Surat)
🏢 Envision Scientific
📍 Surat