Regulatory Affairs Specialist 2 CR

Bachelor’s degree engineering or related field or equivalent.

Strong working knowledge of medical device regulations (21CFR) and FDA law 

Strong working knowledge of the regulatory requirements related to European medical device directives, additional experience with international registration requirements highly desirable 

Capacity to communicate regulations to technical functions within the company 

Ability to work with Regulatory Affairs Management to manage relationships with FDA and international customers (e.g., regulatory agencies, distributors, etc.) 

Experience with document control systems such as Agile and Oracle 

Medical device software submission and validation experience highly desirable