Position Overview
A medical device client is hiring a permeant Sr. Regulatory Specialist, onsite in Maple Grove, MN. This person will assist with medical writing (including preparation and/or finalization of test reports), regulatory filings, review of marketing materials, etc. This Senior Regulatory Specialist will play a key role in ensuring global regulatory compliance for our innovative transcatheter heart valve technologies. This position is responsible for preparing, reviewing, and finalizing technical and regulatory documentation—including test reports, regulatory submissions, and labeling—to support IDE, PMA, and other international filings. An ideal candidate brings strong writing and analytical skills, a solid understanding of medical device regulations, and the ability to translate complex technical information into clear, compliant documentation. This individual will help keep our client’s products and processes aligned with evolving regulatory standards while enabling timely global submissi...