OVERVIEW
We are currently searching for a skilled professional to join a well-known client's team as a Remote Regulatory Affairs Specialist. The Regulatory Affairs Specialist role will independently provide EU regulatory requirements and guidance to EU MDR project teams. Lead the preparation of the EU MDR technical documentation for Class III, IIa, IIb, or Class I sterile or reusable medical devices to support timelines for CE marking and EU commercial release. Lead the submittal of the EU MDR technical documentation for Class III, IIa, or IIb medical devices and collaborate with the cross-functional team and Notified Body to respond to any questions during the review.
RESPONSIBILITIES
EXPERIENCE
TOOLS AND EQUIPMENT USED
Normal office environment: must be computer literate and familiar with Microsoft Suite of Products including Word, Excel, Outlook or similar.
EDUCATION
Minimum of Bachelor's Degree in Science, Engineering, Regulatory Affairs or other technically related required.
Position ID: 509238