Regulatory Executive

Regulatory Executive

• 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.

• 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.

• 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.

• 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: