Katy Johnson Email and Phone Number

Responsible for the review and maintenance of the Technical File Management System required for EU compliance. Provide leadership ensuring that regulatory strategies are developed and implemented in a manner to ensure successful achievement of business goals. Halyard Health Care contact with Notified Bodies to maintain product and facility compliance to European and Australian regulations. Establish and maintain an information network for purposes of monitoring European regulatory developments, followed by appropriate preventive communication and training within Health Care. Support Literature Based Clinical evaluation system for European, Australian and ROW compliance needs. Establish and maintain a process to participate in the review of process/product changes, labeling, claims, complaints, etc., to ensure updates to Technical Files and notified body notifications/prior approvals.

Responsibile for medical device registrations & renewals in Latin America, Mexico, Non-CE Europe, Japan, India, and Asia-Pacific regions. Submit applications to FDA for Certificates to Foreign Goverment and Certificates of a Pharmaceutical Product. Provide regulatory support for import/export issues. Update FURLS Database with new device listings.

Responsibile for medical device registrations & renewals in Latin America, Mexico, and Non-CE Europe. Submit applications to FDA for Certificates to Foreign Goverment and Certificates of a Pharmaceutical Product. Maintain product databases for import/export purposes.