Global Regulatory Affairs Lead for MedTech Submissions

BD in Salt Lake City, UT seeks a Senior Regulatory Affairs Specialist to lead regulatory submissions and ensure compliance across global markets. You will partner with R&D, Quality, Manufacturing, and Marketing to craft robust regulatory strategies for medical devices. The role involves preparing 510(k) submissions, CE technical files, and change notifications while coordinating with health authorities and Notified Bodies. Onsite hybrid work 4 days a week in Salt Lake City.