Regulatory Affairs Manager

Tech Stack

REGULATORY
AFFAIRS
NORTH
OF REGULATORY
TRANSPLANTATION
ORGAN
AMERICA
STRATEGIES
COMPREHENSIVE
FAST-PACED
MANAGER
MANAGER WILL

Job Description

ABOUT ORGANOX:OrganOx has been transforming organ transplantation since 2008, leveraging groundbreaking normothermic machine perfusion technology in our flagship product, the OrganOx metra®.

This technology helps preserve donor livers for up to 12 hours, in efforts to reduce organ discard rates and facilitating more successful transplants.

We are an innovative, fast-paced global medical device company committed to improving transplantation outcomes.

As part of our ongoing expansion in North America, we seek a motivated Regulatory Affairs Manager to join our team.Position SummaryThe position of Regulatory Affairs Manager will work with internal and external partners to deliver innovative products to customers through the preparation of comprehensive regulatory strategies and submissions to achieve marketing approvals in North America.This role will report directly to the VP of Global Regulatory Affairs.Listed below are the major responsibilities of the role and a brief description of some of the key tasks to be performed.

This list is not totally inclusive, and the person will be expected to complete tasks reasonably requested by the VP of Global Regulatory Affairs.