Medical Equipment Regulatory, San Juan

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.