This position manages the domestic and international activities of related product lines for the Regulatory Affairs department according to corporate procedures and policies; U.S. Government policies, primarily the Food and Drug Administration (FDA); applicable State requirements; and European and international regulations and standards.

This position coordinates domestic and international submission preparation and approval by Corporate, and FDA or appropriate international body in a timely manner. Responsible for determining RA strategies for relevant products. This position must recognize potential regulatory issues in day-to-day activities that involve product development through the manufacturing process.

Qualifications:

Bachelor's Degree in Life or Engineering Science

Six to eight years experience as a multi-functional Regulatory Affairs professional or equivalency.

A minimum of three years experience in a supervisory capacity.

Comprehensive knowledge of U.S., European and international regulations and standards covering medical devices.

Knowledge of the clinical application of medical devices, as applicable.

Knowledge of medical device testing methods and statistics, as applicable.

RAC certification preferred