QUALIFICATIONS:  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  (The requirements listed below are representative of the knowledge, skill and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. )

• Understanding of regulations and guidelines governing all phases of Medical Device development with significant guidance and supervision.
• Understanding of new product development requirements and processes with supervision.
• Excellent verbal and written communication skills including presentation skills.
• Time management and project management skills are essential.

Required Education and/or Experience:  Requires a Bachelors degree.  1 to 3 years of experience in regulatory of medical devices required (orthopedics strongly preferred).  Working knowledge of US FDA and EU MDD/MDR.    

Preferred Qualifications:

• RAPS certification
• Experience writing technical files and 510k submissions
• Change Control Management
• Implementation of Process Improvements