**PURPOSE AND SCOPE:**

Develops regulatory strategies for assigned products/product lines. Prepares regulatory submissions required to market new or modified medical devices in the domestic and international clinical markets. Develops and maintains procedures and systems designed to ensure the product development process addresses all regulatory requirements as well as the objectives of the business.

**PRINCIPAL DUTIES AND RESPONSIBILITIES:**

+ Responsible for the day-to-day oversight and management of assigned projects. Serves as the primary regulatory resource for change to and prioritization of projects, resource assignment and efficient management of the development and change processes.
+ Has wide-ranging experience, and uses professional concepts in developing resolution to critical issues and broad design matters.
+ Understands and interprets U.S. and international medical device regulatory requirements, provides guidance on requirements to pr...