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 [Confidential Information] or WhatsApp on +91 95125 93131
