Regulatory Affairs Specialist 2 CR

Alajuela, Costa Rica

+ **Education:**
+ Bachelor’s degree engineering or related field or equivalent.
+ **Experience:**
+ Minimum of 2 years’ experience in similar job position

+ **Specialized Knowledge (Desirable):**
+ 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
+ Certified Regulatory Affairs ...