Regulatory Affairs Specialist

Envision Scientific; Surat; On-site; INR 3,200,000 - 4,800,000; Full time

Job summary

Envision Scientific is seeking a seasoned Regulatory Affairs professional with 36 years of experience in the medical device industry. The role supports global regulatory submissions, product registrations, regulatory compliance, and lifecycle management.

Responsibilities include preparing and maintaining regulatory dossiers, ensuring compliance with EU MDR, FDA, and ISO 13485, and coordinating with cross-functional teams to meet submission timelines.

Qualifications

• 36 years of Regulatory Affairs experience in the medical device industry.
• Strong knowledge of EU MDR, US FDA medical device regulations, ISO 13485.
• Experience in preparing and reviewing regulatory technical documentation.
• Understanding of medical device classification, registrations, labeling, and change control.

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 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 and applicable standards and assess their impact.
• Maintain regulatory records and ensure documentation is audit-ready.
• Support internal, external, and regulatory audits/inspections.

Skills

Regulatory affairs expertise

Regulatory submissions

Documentation & reporting

Coordination & cross-functional work

Regulatory timelines management

Education

Bachelor's/Master's in Pharmacy or Life Sciences or related

Job description

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.