Senior Medical Device Regulatory Affairs Specialist

OrganOx Limited in the United States (hybrid in Madison, NJ) seeks a Senior Regulatory Affairs Specialist to lead regulatory activities across the product lifecycle for assigned devices. You will develop regulatory strategies, assess changes for regulatory impact, and prepare submissions for the U.S.

market and other jurisdictions. The role requires deep experience in regulatory affairs within the medical device sector, US Class III device familiarity, and ability to travel up to 5%.