Regulatory Affairs - medical devices

Key Responsibilities:

Manage and support medical device registration activities for Class I devices in international markets.

Prepare, review, and compile registration dossiers and supporting documentation.

Coordinate submissions with local representatives, distributors, consultants, and regulatory authorities.

Track registration status, approvals, renewals, and regulatory commitments.

Review product labeling, IFUs, declarations, certificates, and technical documentation.

Support responses to regulatory authority queries and requests for additional information.

Maintain registration databases and regulatory records.

Monitor regulatory requirements and changes in assigned markets.

Markets in Scope:

Latin America

Middle East

Asia-Pacific

Africa

Eastern Europe

If this opportunity is of interest and you are available to start in the near term, please reply with your updated CV and availability.