• Handle product registration, renewal, and variation applications for submission to the FDA and other relevant agencies.

• Ensure compliance with all applicable medical device/supplies regulations.

• Prepare, review, and maintain regulatory documents, licenses, and certificates.

• Coordinate with internal departments, manufacturers, and importers regarding documentation and compliance requirements.

• Monitor updates on FDA and regulatory guidelines to ensure continued adherence to current standards.

• Liaise with FDA officers and inspectors during audits and inspections.

• Provide timely responses to queries and concerns from regulatory authorities.

• Support Sales and Marketing in matters related to product registration and regulatory compliance.

• Prepare and review bidding documents, particularly for government hospital bidding.

•Maintain organized records and filing systems for regulatory documents.

• Perform other related tasks as may be assigned from time to time.