About the Role:

We are looking for a detail-oriented and proactive Regulatory Executive to join our team at GMP MediTech, Visnagar, Gujarat.

Key Responsibilities:

• Prepare and maintain regulatory submissions and dossiers for product approvals in India and export markets.
• Ensure compliance with regulatory bodies such as CDSCO, ISO 13485, CE, US FDA (as applicable).
• Coordinate with R&D, Quality, and Production teams to gather technical documentation.
• Maintain up-to-date regulatory files and product registration databases.
• Draft and review regulatory documents such as Device Master Files (DMF), Technical Files, and Risk Management Reports.
• Liaise with consultants, auditors, and government authorities regarding regulatory inspections or inquiries.
• Monitor changes in regulations and notify relevant departments for implementation.
• Ensure labeling, packaging, and instructions for use (IFU) comply with regulatory requirements.
• Support internal and external audits related to regulatory compliance.
• Assist in timely renewal and maintenance of licenses, certificates, and product registrations.
• Maintain records for regulatory submissions and correspondence.

Required Qualifications:

• Bachelor’s degree in Pharmacy, Biomedical Engineering, Life Sciences, or a related field.
• 1–3 years of experience in regulatory affairs, preferably in the medical device industry.
• Familiarity with Indian and international medical device regulatory standards.

Desirable Skills:

• Strong attention to detail and documentation skills.
• Good communication and coordination abilities.
• Prior experience with orthopedic or Class II/Class III medical devices is a plus.

Why Join GMP MediTech?

• Be part of a mission-driven organization advancing orthopedic medical technology.
• Contribute to products that enhance patient outcomes and meet global standards.
• Gain experience working on domestic and international regulatory pathways.
• Thrive in a team-oriented, ethical, and quality-focused environment.

Experience: 1-3 Years
Job Location: GMP MediTech, Visnagar, Gujarat
Apply Now: Email your resume to hrd@gmpmeditech.com or WhatsApp on +91 95125 93131